|Issuer:||Florida District Office|
|Issued:||June 29, 2005||Closed:||
Department of Health and Human Services
Public Health Service
555 Winderiey PI., Ste. 200
RETURN RECEIPT REQUESTED
June 29, 2005
Joseph J . Corasanti, President
310 Broad Street
Utica, NY 13501-1203
Dear Mr. Corasanti:
During an inspection of your subsidiary, Linvatec Corporation, 1131 Concept Boulevard, Largo, Florida on November 29 - December 8, 2004, our investigator determined that your firm manufactures a wide variety of surgical devices including, but not limited to, irrigation pumps, hand pieces and drills used for surgery, and bone and soft tissue fixation devices. These products are medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h). Deviations noted during our inspection are described below. We have also reviewed your responses dated January 10, 2005, amended February 28, 2005 and April 21, 2005, and have commented below on the adequacy of your responses.
The above-stated inspection revealed that these devices are adulterated under section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:
1. Failure to establish, maintain, and implement procedures for corrective and preventive action (CAPA), including identification of the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).
A. Your firm continued to receive complaints related to device failures over an extended period of time -- 2466 complaints in 4 years regarding hand pieces overheating and pneumatic and electric powered rotary devices causing burns to patients and users. Your firm concluded the majority of these complaints were caused because the users failed to return the hand pieces for preventative maintenance. However, your firm failed to take appropriate and effective action to prevent recurrences of this problem, such as warning users of the potential for injuries when required preventive maintenance is not done.
B. Your firm received 772 complaints related to pump devices running continuously, some of which resulted in patient injuries including exposing patients to extravasation(s). Your firm failed to take adequate preventive action to prevent further occurrence of this nonconformance, such as assuring that the Instructions for Use and priming procedures are adequate in your User Manuals.
C. More specifically, complaint 6436, dated April 13, 1999, references an oscillating saw, with the safety off, starting by itself while lying on the patient's leg. The patient's calf was lacerated. No further investigation or corrective and preventive action was taken by your firm.
2. Failure to analyze complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. 21 CFR 820.100(a)(1). Your firm fails to conduct an appropriate analysis of complaints and reports of nonconforming product in that:
A. You fail to examine complaints by failure mode, and multiple failures reported for devices from a single lot are not individually analyzed.
B. Your firm received a complaint regarding sharp metal shards shooting out of the back of a new pin driver during surgery. The complainant reported repeated problems with reliability of this product; however, you did not compile or analyze the number and types of failures.
C. Complaints with defect code (125) which stands for "No Device Returned" are not accounted for in any statistical analysis of device failures or complaints.
3. Failure to establish, maintain, and implement corrective and preventive action procedures for verifying or validating corrective and preventive actions to ensure that such actions are effective and do not adversely affect the finished device as required by 21 CFR 820.100(a)(4).
A. Your firm's CAPA procedure lacks a requirement that any corrective or preventive actions implemented are verified or validated to ensure that they do not adversely affect the finished device.
B. 13 complaints were received between May 1997 and October 1999, referencing Bioscrew Tap devices which broke. Investigation of reported complaints was not initiated until February 16, 1999, when it was determined that the failure was due to an inadequate weld completed by a sister plant (Shutt Medical, California). A recall was not initiated until December 20, 1999. You also received a complaint in October 2002 regarding this device, and determined that the product should have been recalled. Thus, your firm failed to conduct an timely, adequate investigation of the complaints received, and failed to verify that your corrective action -- the recall -- was effective.
C. Software flags were added to rechargeable batteries after complaints were received referencing the battery's depletion during surgery. No verification or validation of this corrective action was conducted.
4. Failure to validate processes with a high degree of assurance and approve according to established procedures where the results of a process-cannot be fully verified by subsequent inspection and test. 21 CFR 820.75(a). In 2003, you ethylene oxide (EO) contract sterilizer and EO cycle were changed including a reduction in time and temperature, as well as the addition of 2 vacuum purge cycles in 2003. Only one packaging run was conducted to validate the seal strength after sterilization, which is insufficient to demonstrate that the process produces consistent results.
5. Failure to establish and maintain procedures for validating and implementing device design as required by 21 CFR 820.30(g). A warning statement was incorporated into the User's Manual for High Speed Handpieces, including two Trigger PowerPro models, concerning the possible overheating of the device and the potential for patient burns if preventive maintenance is not done on a scheduled basis. This warning statement was not validated to assure that the target audience was receiving and understanding the message.
6. Failure to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met as required by 21 CFR 820 .80(c). Your acceptance procedure is inadequate in that it allows employees to audit their own work. For example, a Linvatec employee who assembled a Microchoice Footswitch also completed the inspection of the work. The footswitch was then released without meeting specifications, resulting in a January 2003 recall.
7. Failure to include or refer to the location of, in device history records, acceptance records that demonstrate a device is manufactured in accordance with the Device Master Record (DMR) as required by 21 CFR Part 820.184(d). There is no record of testing with a Gauss meter of incoming magnets used to manufacture High Speed Shavers from 1995 until mid 2000, although your engineering drawings require this testing.
Your devices are also misbranded within the meaning of section 502(t)(2) of the Act [21 U.S.C. 352 (t)(2)] in that your firm failed to furnish material or information required by or under section 519 of the Act (21 U.S.C.360i) respecting your devices, including information required under 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to the following:
Device manufacturers are required to report to FDA within 30 days whenever the manufacturer receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device marketed by a manufacturer: (1) may have caused or contributed to a death or serious injury; or (2) has malfunctioned and such device or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. 21 CFR 803.50(a)(1)-(2).
1. You received complaints 67566 and 67567, dated August 2, 2001, referencing two Apex pumps which ran continuously and caused extravasation in the patient's shoulder. The surgical procedure had to be changed from a closed procedure to an open procedure because of this malfunction. An MDR was never submitted.
2. [redacted] reported two incidents of electrocautery tips breaking off during surgery (Complaint 33002, dated March 16, 2000.) However, only one MDR was submitted on April 13, 2000. A second MDR was not submitted despite the report that the tip of the device was recovered from the patient.
3. A MDR was not submitted to FDA for Complaint 70156, dated September 12, 2001, regarding a piece of Model C8740 cannula that broke off in a patient's shoulder.
4. A MDR was not submitted to FDA for Complaint 97679, dated October 10, 2002, regarding a Bioscrew Tap that broke during an operation requiring that the incision be enlarged.
5. An MDR was submitted on May 23, 2003, more than 30 days after a Linvatec sales representative was made aware of extravasation, compartmental syndrome, fasciotomy, continued symptoms, and visits to ER by a patient on April 9, 2003.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.
We received your firm's response dated January 10, 2005, and your amended responses dated February 28, 2005 and April 21, 2005, to the Form FDA 483, Inspectional Observations, issued to Gerald G. Woodard, President, Linvatec, on December 8, 2004. These responses promise corrective and preventive actions relating to the observations and indicate that some actions have been completed. However, your responses do not contain sufficient documentation to allow FDA to assess the adequacy of your completed and pending actions. All responses to our FDA 483 observations should include any necessary complaint investigation, statistical analysis, design control and CAPA information. All procedural revisions should be fully described and supported by adequate documentation including standard procedures, validation protocols, and where appropriate, complete data and data analysis.
Corrections to all observations must be substantially complete and documented prior to our re-inspecting your facility. Your firm's responses dated January 10, and amended February 28, 2005 and April 21, 2005 are inadequate for the following reasons:
FDA 483, Item #l A
Your response fails to analyze the complaints that reference overheating and to identify a root cause for the overheating. Your response describes a communication to users about preventive maintenance as a preventive action. However, you do not discuss why this is an effective preventive action or include a copy with your response. Your response states that the instruction manuals and inserts have been revised to strengthen preventative maintenance schedules. However, you did not include copies of the revisions or the validation to ensure how effectively the message was conveyed and understood by users.
FDA 483, Item #1B
Your response fails to identify the action(s) needed to correct and prevent pumps from running continuously. It also fails to provide sufficient documentation to allow FDA to
assess the adequacy of your completed actions.
FDA 483, Item #1C
Your response includes training of users and employees and revising procedures and labeling to prevent user error. It states that some actions have been completed, but fails to provide sufficient documentation that these actions correct and prevent the identified problems.
FDA 483, Item #1D
In addition, it does not provide sufficient documentation of completed actions such as training and modification of procedures.
FDA 483, Item #2
FDA 483, Item #2A, B, E, F
Please provide documentation of specific instructions, guidelines, and staff training described in your response.
Your response to Item #2B states that the action is complete but there is no documentation.
FDA 483, Item #s C & D
Your response states an assessment of training effectiveness is complete, but does not document the results of the investigation, revisions of the training procedure, or the effectiveness of corrective actions.
FDA 483, Item #3
FDA 483, Item #3A
This response appears to be adequate
FDA 483, Item #3B
Please provide documentation of the activities you identified in your response as completed (i.e., revised procedures)
FDA 483, Item #4
Your response states that the packaging post sterfiization has been completed; please provide documentation of the results.
FDA 483, Item #5
Your response does not provide sufficient documentation of the revised procedures or that a review of device design validation for marketed products was successful
FDA 483, Item #6
Please provide documentation of the described corrective actions
FDA 483, Item #7
Your response does not include sufficient documentation to allow FDA to assess the adequacy of your actions. Please provide documentation, including an assessment of the effectiveness of the corrective and preventive actions.
FDA 483, Item #8
FDA 483, Item #8A
A. Your response does not provide sufficient documentation of the review or update of the complaint and CAPA procedures or staff training.
B. Similarly, your response states that a resource was added to facilitate a return goods/complaint database to identify complaint trends. However, the resource is not identified, and no documentation is provided showing how the database will work within the Master Quality and Regulatory System Plan.
FDA 483, Item #8B
Your response fails to include documentation of the results of your failure investigation of Complaint 141504. An investigative report showing the information that was collected, any investigation and the resulting actions that took place after the investigation should be provided.
FDA 483, Item #8C, #8D and #8E
Your responses may be adequate, but you did not provide sufficient documentation to allow FDA to assess the adequacy of the actions taken.
FDA 483, Item #9
Your responses states that MDRs have been submitted or will be shortly for the four cases that were previously not reported. However, there is no discussion regarding your original failure to file these documents and no documentation showing your updated MDR procedures.
FDA 483, Item #10
Your responses state that MDRs were submitted for two complaints # 67566 and 67567 to FDA, and that a retrospective review of complaints will be conducted. No documentation of the completed actions, such as copies of your revised MDR procedures, was provided.
FDA 483, Item #11
Your response may be adequate. Please provide additional information regarding the review of quality record retention procedures as described in your response. Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket submissions for class III devices to which the Quality System regulation deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Govermnents will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or initiation of procedures to impose civil money penalties.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions about this letter, you can contact Mr. Couzins at (407) 475-4728.
Emma R. Singleton
Director, Florida District