- TFS Manufacturing Pty Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
DEC 21, 2015
VIA UNITED PARCEL SERVICE
Paul A. Zadow
Managing Director and Owner
TFS Manufacturing Pty Ltd.
3 Charles Street
Allenby Gardens 5009
Dear Mr. Zadow:
During an inspection of your firm located in Allenby Gardens, Australia, on August 17, 2015, through August 20, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a sterile mesh implant system. 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 to affect the structure or function of the body.
This 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received aresponsefrom you,dated September 9,2015,concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for verifying the device design, and to document the results of the design verification, including an identification of the design, methods, the date, and the individuals performing the verification, in the Design History Files (DHF), as required 21 CFR 820.30(f). For example:
a. Your firm has not established design verification protocols and design verification acceptance criteria for Polypropylene Mesh Implants; and
b. Your firm's design verification report, Mechanical Testing Polypropylene Mesh Implant, dated July 3, 2015, does not include the test dates, names of the individuals who have conducted the testing, and the calibration status of equipment used for the testing.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response indicated that the design verification test methods and protocol were documented informally. The response additionally indicated that design procedures and design documents will be retrospectively reviewed and updated where appropriate. Your firm submitted an addendum to the Mechanical Testing of Polypropylene Mesh Implant report. However, the report did not identify or reference acceptance criteria.
2. Failure to establish and maintain procedures for corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example:
a. Your firm's CAPA procedure, SOP (b)(4), does not include the requirements for:
i. Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other source of quality data to identify existing and potential causes of nonconforming product or other quality problems;
ii. Establishing appropriate statistical methodology where necessary to detect recurring quality problems; and
iii. Verifying or validating corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.
b. Your firm initiated CAPA 008 to address a change in the sterile packaging process that was implemented without shelf life revalidation for the TFS001sterile implant system. However, your firm's CAPA report does not document the CAPA investigation results.
c. Your firm initiated CAPA 006 to address five nonconformances associated with your firm's contract sterilizer, including failing to document all activities and critical parameters associated with Ethylene Oxide (EtO) sterilization validation. As part of CAPA activities, your firm revalidated the EtO sterilization process and established the requirements for (b)(4) sterilization cycle rather than one. However, your firm's CAPA report does not have:
i. Documentation of the investigation into the causes of why a new sterilization validation was required;
ii. Documentation of the actions taken to address the five nonconformances; and
iii. Shelf life validation for packages exposed to (b)(4) sterilization cycles.
We reviewed your firm's response and conclude that it is not adequate. Your firm revised its CAPA procedures and forms to address the procedural deficiencies listed above. Your firm has conducted training on the revised procedures, and your response indicated that a retrospective review of previous CAPAs is in progress. However, your firm's response did not evaluate the risk associated with products that were released following the unvalidated sterilization cycles and take mitigation actions as necessary. In addition, your firm's response did not include personnel training records on the revised CAPA procedures and forms.
3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
a. Your firm's complaint handling procedure does not specify the timeframe for determining if a complaint represents an event which must be reported to FDA under 21 CFR Part 803, Medical Device Reports (MDRs).
b. Your firm has not evaluated (b)(4) complaints to determine if each complaint represented an event which must be reported to FDA. These complaints allege incontinence and device eroding through vaginal wall, contributing to hemorrhage and painful reaction.
The adequacy of your firm's response cannot be determined at this time. Your firm updated its complaint handling procedure to address the above procedural deficiencies. Your firm has conducted personnel training on the revised procedure. The response indicated that your firm will conduct a retrospective review of complaints for MDR reportability. However, the results of this review were not provided in your response. We will review a summary of your firm's results of this retrospective review once completed.
4. Failure to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on evaluation results, as required by 21 CFR 820.50(a)(2). For example, your firm's purchasing control procedure, "Evaluation of Suppliers and Subcontractors," SOP Number (b)(4), Version 4, does not define the actions to be taken when the annual evaluation results for a supplier are "poor" [unacceptable].
The adequacy of your firm's response cannot be determined at this time. The response indicated that your firm will update its supplier control procedure to address the above procedural deficiency. However, the updated procedure was not provided in your response. We will review evidence of implementation of your firm's corrective actions, including your firm's revised supplier control procedure and training documentation.
5. Failure to establish procedures for quality audits and conduct such audits to assure the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example:
a. Your firm's quality audit procedure, "Internal Audits," SOP Number (b)(4), does not have the requirements that the quality audits will be conducted by individuals who do not have direct responsibility for the matters being audited.
b. Your firm's document control audits dated July 18, 2013, and December 9, 2014, were both conducted by an individual who is responsible for the area of document control.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response included an updated quality audit procedure which adequately addressed the above procedural deficiency. Your firm conducted personnel training on this revised procedure. However, your firm's response did not explain how previous audits that were potentially inadequate will be prioritized or given additional review to ensure that audits were done adequately.
Given the serious nature of the violations of the Act, the devices manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C.§381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you regarding the adequacy of your firm's response and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. federal agencies may be advised of the issuance of 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 Ill devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected.
Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation notin English to facilitate our review. We will notify you regarding the adequacy of your firm's responses and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
's response should be sent to
: Food and Drug Administration
, Center for
Devices and Radiological Health
, Office of Compliance
, Field Inspections Support Branch
, White Oak Building 66
, Rm 3523
, 10903 New Hampshire Ave.
, Silver Spring
, MD 20993. Refer to CMS case #480653 when replying. If you have any questions about the contents of this letter
, please contact Shumaya Ali
, Acting Chief, Foreign Enforcement Branch, at email@example.com
(email) or +1(240) 402-4020 (telephone)
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the lnspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
CAPT Sean Boyd, MPH, USPHS
Office of Compliance
Center for Devices and Radiological Health