Scottcare Corporation 2/21/12
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
February 21, 2012
VIA United Parcel Services
Kenneth M Zajaczkowski
4791 W 150
Cleveland, OH 44135
Dear Mr. Zajaczkowski:
During an inspection of your firm located at 2880 Clemson Road, Westlake, OH 44145 on January 9-13, 2012, an investigator from the United States Food and Drug Administration ("FDA") determined that your firm is the manufacturer of telemetry devices. Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h)
, this product is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
This inspection revealed that the medical 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 manufacturing, 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 (CFR), Part 820.
We received your response dated January 26, 2012 to our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address your response below, as it relates to each of the noted violations. These violations include, but are not limited to, the following:
Failure to establish adequate procedures for implementing corrective and preventive action that shall include analyzing processes, work operations, concessions, audit reports, quality reports, complaints, returned product, and other sources of quality data, using appropriate statistical methodology, to identify existing and potential causes of nonconforming products, or other quality problems, as required by 21 CFR § 820.100(a)(1)
Your two procedures that address analyzing data sources, “QSP04-003 CORRECTIVE AND PREVENTIVE ACTION” procedure, Rev C, dated 9/27/07 and “QSP05-003 CUSTOMER FEEDBACK AND POST-PRODUCTION MONITORING” procedure, Rev A, dated 3/30/06, do not address, how data sources will be analyzed; how often they will be analyzed; and the statistical methods that will be utilized to analyze the quality data to identify existing and potential causes of nonconforming product or other quality problems.
Specifically, your firm is not analyzing complaints based on a statistical methodology that will detect recurring quality problems. A total of 41 of the 157 complaints for TeleSentry devices were due to a “bad SD card”. Your firm has not identified this as a potential cause of nonconforming product through data analysis; and no CAPAs have been initiated.
Your response to this observation is not adequate. Your revised “QSP04-003 CORRECTIVE AND PREVENTIVE ACTION” procedure does not address the statistical methodology that will be utilized to analyze your data sources, and what thresholds will trigger the initiation of a CAPA.
Failure to verify the corrective and preventive action to ensure such action is effective, as required by 21 CFR § 820.100(a)(4)
Specifically, five of the eleven corrective actions (CAPAs) reviewed did not have effectiveness checks performed.
Your response states that you are reviewing all CAPAs that have been initiated since the last FDA inspection (2009) and these CAPAs will be followed-up on per your new procedure. Please provide an update on the progress of this review.
Failure to establish and maintain procedures adequate procedures receiving, reviewing and evaluating complaints by a formally designated unit, as required by 21 CFR § 820.198(a)
Specifically, 10 of the 11 “non-complaint” records reviewed by the FDA investigator meet the definition of a complaint.
Your response states that you have revised your procedure and removed the term, “non-complaint”. It also states that all “non-complaints” received since the last FDA inspection (2009) will be reviewed to determine if they are complaints. Those reclassified as complaints will be assigned codes for data analysis and reviewed for failure investigation requirements, MDR reporting and the need for corrective action. Please provide an update on the progress of this review.
Failure adequately review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR § 820.198(c)
Specifically, a total of 3 of the 17 complaints reviewed had inadequate investigations. For example, a customer reported they received six new TeleSentry devices and one of the devices had old firmware. There was no investigation to determine why the new device had the old firmware.
Your response to this observation is not adequate. It does not address performing a retrospective review of complaints to determine if adequate investigations were performed.
Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria; and failure to document these activities, as required by 21 CFR § 820.80(d)
and (e). Specifically
Your two procedures that address finished device acceptance for the TeleSentry devices, “WI06-094 TeleSentry Device Assembly”, Rev B, dated 12/12/11 and “WI06-096 Standard TeleSentry Test”, Rev B, dated 12/12/11, state to call QA for inspection; but neither procedure establishes acceptance criteria for QA to determine acceptance.
A total of 3 of 15 device history records (DHRs) reviewed did not contain WI06-094-F1 “TeleSentry Assembly Traveler” form, which is used to document finished device acceptance.
Your response to this observation is not adequate. You do not state whether you expanded your review of device history records to other devices you produce to determine if other DHRs are missing required documents. Additionally, you state you are filing all DHRs in a newly created, single location, but did not provide any written procedures detailing this requirement, or any records showing employees have been trained to place these documents in this new location.
Failure to establish procedures for identifying training needs and ensure that all personnel trained to adequately perform their assigned responsibilities, as required by 21 CFR § 820.25(b)
Specifically, employees in the Customer Service Department are classifying communications that meet the definition of a complaint as “non-complaints”.
Your response to this observation appears adequate. The adequacy of your corrective action will be determined during a future inspection.
Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation, as required by 21 CFR § 820.30(i)
Specifically, your firm received a complaint from a customer on 8/24/11 reporting a potential serious bug with the TeleSentry software, version 1.1.0 that they were beta testing at their site.
This software version has not been approved; and your “QSP03-008 DESIGN CHANGE CONTROL” procedure, Rev C, dated 02/27/08 does not address and/or allow beta testing of software at customer locations prior to release of the engineering change order.
Your response to this observation can not be assessed at this time. Your response states you are currently evaluating the processes, controls and documentation to better define the release of software to Beta test sites. You further state you will provide the FDA with an update within 30 days regarding this issue, and you will not provide software to customers without an approved ECO.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in the initiation of regulatory action without further notice. This may include, but is 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 applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations 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 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 the corrective actions you have taken. If your planned corrective actions 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.
Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 2167, or you may forward a facsimile to her at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violations noted in this letter and in the FDA 483s 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 action to correct the violations and to bring your products into compliance.
Paul J. Teitell