|Issuer:||Atlanta District Office|
|Issued:||June 11, 2008||Closed:||
Department of Health and Human Services
Public Health Service
Atlanta District office
June 11, 2008
VIA FEDERAL EXPRESS
Michael A. Mazza, President
1931 Norman Drive
Waukegan, IL 60085
Dear Mr. Mazza:
During an inspection of your firm located in Jesup, GA on 3/31/08 through 4/2/08, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures disposable and reusable hot and cold compresses for pain therapy. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
The inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R), Part 820. At the conclusion of the inspection, our investigators issued a Form FDA 483, List of Inspectional Observations, to Mr. Casey E. Guzniczak, Director of Quality Control and Regulatory Affairs (copy enclosed). The violations noted during our inspection include, but are not limited to, the following:
1. Failure of management with executive responsibility to ensure an adequate and effective quality system is implemented and maintained at all levels of the organization, as required by 21 CFR 820.20. Specifically, your firm has not successfully implemented corrective and preventive actions as a follow-up to external and internal audit findings in April 2007. You indicated to our investigator that efforts were made to correct the Quality System (QS) deficiencies identified in the April 2007 audit; however management concluded that your firm lacked the necessary resources/personnel to accomplish the required tasks internally. You indicated that a recent external audit was performed on March 11-12, 2008 and that you are currently in the process of evaluating the results of the audit.
2. Failure to validate a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). Specifically your firm has not documented that the processing parameters used for sealing water bags on the Water Bag Machine, Vertical Packaging Machine, and the Emplex Rotary Band Heat Sealers have been validated.
3. Failure to investigate complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c). Specifically, Complaint # 2007-11-001 received on 11/2/2007 which involved a burned cornea was not investigated. There was no follow-up with the customer and the complaint status remains open awaiting customer call back. Complaint # 2007-09-009 dated 9/25/2007 which indicated that when the customer pulled 15 packs of the Compress Instant Ice Junior from the drawer, the customer noted that they had burst and the gel was leaking out of the cold packs. While the customer supplied a lot number, no investigation or additional follow-up was conducted. The complaint status remains as "awaiting supplier response".
4. Failure to implement procedures for corrective and preventive actions (CAPAs), as required by 21 CFR 820.100(a). Specifically, several CAPAs (2007-CAPA-002 through 005) were initiated by your firm as a follow-up to an outside audit of your facility which was conducted on April 3, 2007. As of the date of our inspection, your firm was not able to demonstrate that these CAPAs were implemented.
5. Failure to establish a Device Master Record to include or refer to the location of all productions and process specifications, as required by 21 CFR 820.181(b). Specifically, your firm has no documented specifications and acceptance criteria for the devices manufactured at your facility. Your firm has no assurance that the finished devices conform to any established specifications.
6. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, your firm does not have a procedure to identify, evaluate, investigate and disposition nonconforming product. Nonconforming products are currently either reworked or discarded. Your firm indicated that you were in the process of implementing a procedure for handling non-conforming products.
7. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities; such training shall be documented, as required by 21 CFR 820.25(b). Specifically, your employee training program has not been implemented and there are no employee training records.
8. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1). Specifically, your firm has not evaluated your suppliers and contractors. There are no procedures in place to assure that suppliers and contractors will be evaluated; and currently there are no written agreements with suppliers and contractors which define their responsibilities.
Our inspection also revealed that your Compress Instant Ice Junior is misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 or the Act, 21 U.S.C. 360i, and 21 CFR Part 803-Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to submit an MDR within 30 days of receiving or otherwise becoming aware of information that reasonably suggested that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). Specifically, MDRs were not submitted for the following complaints:
1. Complaint # 2007-11-001 dated 11/2/2007. The complainant reported that while a physician's assistant was breaking the compress (Compress Instant Ice Junior) to mix the inner ingredients together, the mixture squirted out of a previously unknown slit in the comer of the unit into the eye of the physician's assistant. The physician's assistant went to the emergency room and was diagnosed with a burned cornea. The complaint summary indicated that there was no response back from the complainant about sample information or availability as of 12/4/07. No additional documentation or follow-up was conducted by your firm.
2. Complaint # 2008-01-012 dated 1/15/2008. This complaint involved the Compress Instant Ice Junior which was activated in the usual manner, but then leaked into the patient's eye. The eye was lavaged and the patient was treated by the ophthalmologist the next day. The complaint summary indicated that the lot number provided by the complainant was invalid and thus a thorough investigation could not be performed.
3. Complaint # 2008-03-009 dated 3/7/2008. This complaint involved the Compress Instant Ice Junior where the end user received frostbite on the lower back after using the cold pack for approximately 15 minutes. The complaint summary indicated that the end user did not follow the instructions for use.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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 civil money penalties. Also, 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, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations related to the subject devices have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of any corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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. Please send your response to Serene N. Ackall, Compliance Officer at 60 Eighth Street, NE, Atlanta, GA 30309. If you have any questions about the content of this letter please contact Serene N. Ackall at 404-253-1296.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observation, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Mary H. Woleske
Cc: Mr. William G. Aldredge, General Manager
1788 W. Cherry St.
Jesup, GA 31545-0629