Pega Medical Inc. 10/26/10
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue |
Silver Spring, MD 20993
OCT 26 2010
VIA UPS EXPRESS
Ariel R. Dujovne
Pega Medical Inc.
1105 Autoroute Chomedy
Laval, Quebec, H7W5J8, Canada
Dear Mr. Dujovne:
During an inspection of your firm located in Laval, Quebec, Canada on March 29, 2010 through March 31, 2010, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Fassier-Duval IM Telescopic System and the Hinge Pediatric Plating 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 are intended to affect the structure or function of the body.
This inspection revealed that your Hinge Pediatric Plating System and Fassier-Duval IM Telescopic System devices are 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 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation.
We received a response from Mr. Enrique Garcia, M.Eng, Quality Manager & Director of Engineering dated April 20, 2010 concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
Failure to adequately develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
For example, your firm’s MDR procedure identified as PEGA MEDICAL QUALITY ASSURANCE PROCEDURE, QAP 8.5.2, CORRECTIVE & PREVENTIVE ACTION, Revision: C, fails to include information about the following as required by section 803.17 of Title 21 of the Code of Federal Regulations:
a. a process for how the facility will meet its requirements for
i. timely and effective identification, communication, and evaluation of events that may be subject to the MDR requirements [21 CFR 803.17(a)(1)]
ii. a standardized review process or procedure for determining when an event meets the criteria for MDR reporting [21 CFR 803.17(a)(2)]
iii. timely transmission of complete medical device reports to FDA as required [21 CFR 803.17(a)(3)]
b. Documentation and record-keeping requirements for:
i. information that was evaluated to determine if an event was reportable [21 CFR 803.17(b)(1)]
ii. all medical device reports and information submitted to the FDA [21 CFR 803.17(b)(2)]
iii. systems that ensure access to information that facilitates timely follow up and inspection by FDA [21 CFR 803.17(b)(4)]
We have reviewed your response and have concluded that it is inadequate because no evidence of implementation of your action plan was provided. Your Medical Device Reporting procedure should include all of the elements listed above.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)) Also, U.S. 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 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 the corrective action 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. If the documentation is not in English, please provide a translation to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies of the following 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. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a).
For example, Complaint NCR No. (b)(4) reported the inner tube of the 6.4 sleeve of FD-Nail, Part No. (b)(4), Job No./Order No. (b)(4), broke at the weld. CAPA No. (b)(4) was initiated and a new design was introduced by the supplier to part No. (b)(4) to add a traversal pin to the welded section of the tube as reported in section H of the document entitled, “Attachment B Guide for Devices”. No specified requirements were established to ensure appropriate design change controls (e.g. documentation, verification or validation, review, and approval) were applied by the supplier.
We have reviewed your response and have concluded that it is inadequate. According to the response, your firm plans to issue an Engineering Change Order to document the design change made to the instrument. Your firm also plans to conduct and document a validation of the design change. However, no supporting documents were provided in your response. Your firm’s response did not address systemic corrective action. Your firm has not determined why appropriate purchasing controls (e.g. the provision of appropriate quality requirements to suppliers) were not established to begin with or whether appropriate quality requirements (e.g. the specified application of design change controls) have been provided to other suppliers.
2. Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses, as required by 21 CFR 820.30(g).
For example, your firm’s steam sterilization validation of the Hinge Pediatric Plating System was incomplete as evidenced by (b)(4) #(b)(4), Procedure (b)(4) Rev 3, Protocol (b)(4) Rev 01, date issue 07 August 2008. The device is distributed to customers non-sterile and the receiving facility performs the steam sterilization prior to use under prescribed instructions your firm has not successfully validated. Your firm only performed steam sterilization validation on size 12 mm of batch (b)(4), lot #(b)(4)and Report #(b)(4) did not identify the Hinge Plate, but its screw's accessories. The Hinge Plating System is distributed in three sizes in which your firm should have addressed the worst-case scenario. Your firm was unable to provide a rationale for selecting implant size 12 to for the steam sterilization study.
We have reviewed your response and have concluded that it is inadequate. According to your response, demonstration indicating that the 12 mm Hinge Plate in sterilization validation is the worst-case scenario was not documented. Technical documentation of the Hinge Plate Plating System and the Fassier-Duval IM Telescopic System will be revised in order to include assessment of the worst cases that were evaluated during the sterilization and cleaning validation of the Hinge Pediatric Plating System and the cleaning validation of the Fassier-Duval IM Telescopic System. No evidence of implementation of this correction was provided. Your firm’s response did not address systemic corrective action.
3. Failure to establish and maintain 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).
For example, the dimension of (b)(4) was re-specified as (b)(4) for Hinge Plate Assembly, Part #(b)(4) without evidence of the application of design change controls prior to implementation (e.g. an Engineering Change Order).
We have reviewed your response and have concluded that it is inadequate. According to your response, the firm will issue an Engineering Change Order to correct the engineering drawing to indicate the appropriate tolerances. No evidence of implementation of this correction was provided. Your response did not address systemic corrective action. Additionally, your response did not address why design change control procedures were not implemented for this specific change or whether other changes were reviewed to identify additional nonconformities.
4. Failure to document process validation activities and results, including date and signatures of the individual(s) approving the validation and where appropriate equipment validated, as required by 21 CFR 820.75(a).
b. There is no documented data or rationale supporting that the results of the ultrasonic cleaning validation (Validation Report No. (b)(4)) used for the Fassier-Duval IM Telescopic Nail System can be applied to the ultrasonic cleaning process used for the firm’s Hinge Pediatric Plating System. During the inspection, your firm’s management claimed the validation study was applicable to both products.
c. The major equipment used during ultrasonic cleaning validation of the Fassier-Duval IM Telescopic Nail System was not documented (e.g. (b)(4) and (b)(4) ultrasonic baths). There is no documented justification for not documenting this equipment.
d. There is no documentation that the (b)(4) ultrasonic bath has been qualified for use in cleaning of the Fassier-Duval IM Telescopic Nail System or the Hinge Pediatric Plating System.
We have reviewed your response and have concluded that it is inadequate. According to your response, technical documentation of the Hinge Plate Plating System and the Fassier-Duval IM Telescopic System will be revised in order to include assessment of the worst cases that were evaluated during the sterilization and cleaning validation of the Hinge Pediatric Plating System and the cleaning validation of the Fassier-Duval IM Telescopic System. No evidence of implementation of this correction was provided. Your response did not address systemic corrective action.
5. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, your firm failed to implement Purchasing Procedure QAP 7.4, Rev 00, Subsections b and c of Section 4.1, in that no verification and/or inspection data of Hinge Plate Assembly, Cat #(b)(4), Lot No. (b)(4) was maintained to assure that the supplier/contract manufacturer met the initial supplier evaluation and selection criteria.
We have reviewed your response and have concluded that it is inadequate. Your firm plans to review the procedure for the evaluation of suppliers to clearly indicate the acceptance or refusal of new suppliers in a documented manner. Your firm should establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. Evidence of implementation of the corrective action was not provided in your response. Your response did not identify why supplier evaluation procedures were not conformed with or whether other supplier records were reviewed to determine if similar nonconformities exist.
6. Failure to adequately 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, customer complaint handling requirements documented in Section 4.8 of the firm’s Nonconforming Product Procedure QAP 8.3, Rev 00 did not include provisions for documenting facts associated with the complaint (e.g. complainant address and telephone number, device identification and control numbers); the processing of complaints in a uniform and timely manner; or for the evaluation of the complaint to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803.
We have reviewed your response and have concluded that it is inadequate. According to your response, the firm will create and approve a procedure that will define what should be reported in a complaint, what the time frame for the initiation and disposition of the complaint investigation should be, and how the complaint should be evaluated. The complaint procedures should ensure that all complaints are processed in a timely manner, complaints are evaluated to determine whether an event is required to be reported to FDA under part 803, Medical Device Reporting, and include the complainant’s name, address, phone number, device identification and control numbers used. Your response did not address systemic corrective action. Additionally, your response did not address why appropriate complaint handling procedures were not established to begin with or whether the newly established procedures would be evaluated to determine whether all applicable complaint handling requirements of the Quality System regulation would be met. Evidence of implementation of their corrective action was not provided in your response.
7. Failure to document the disposition of nonconforming product, as required by 21 CFR 820.90(b).
For example, the disposition of nonconformities (returned to supplier) identified in IR No. (b)(4), (b)(4), and (b)(4) was not documented.
We have reviewed your response and have concluded that it is inadequate. According to your response, the firm will review their documentation related to this production batch in order to clarify the series of events that led to this violation. Additionally, the production forms and procedures will be reviewed in order to implement a method to more appropriately control nonconforming product including returns to suppliers. Your firm should establish and maintain procedures that define the responsibility for review and authority for the disposition of nonconforming product. No evidence of implementation of the cited corrective action was provided. Your response did not identify why appropriate procedures for the documentation of the disposition of nonconforming product were not established to begin with. In addition, your firm’s response did not include any evidence that the disposition of nonconforming product was reviewed globally to identify and address additional examples of inappropriate documentation of the disposition of nonconforming product that may exist.
8. Failure to establish and maintain procedure to control all documents, as required by 21 CFR 820.40.
a. The Device Master Record (DMR) for the Hinge Plate wrongly identified the DWG/Catalog Number for Hinge Plate Member Left as (b)(4) and Hinge Plate Member Right as (b)(4). Engineering Change Order (ECO) #(b)(4), attached to the Design History File (DHF), identified the DWG/Catalog Number for the Hinge Plate Member Left as (b)(4), and Hinge Plate Member Right as (b)(4).
b. ECO#(b)(4) documents that Revision C of the design specifications and manufacturing process for the new 20mm Hinge Plate size was completed and effective as of 2/5/09. The master manufacturing process sheet that is part of the Device Master Record (DMR) documents Revision C of the manufacturing process for the 20 mm Hinge Plate size was implemented on 1/12/09.
c. According to Document & Data Control QAP 4.2.3, section 4 (in part): “…documentation generated by Pega Medical…shall pass through the President…” There was no indication that the president was aware of ECO #(b)(4).
We have reviewed your response and have concluded that it is inadequate because your firm did not completely address all items listed in the observation. Your firm corrected the typographical error made on the Manufacturing Process Sheet of the Device Master Record. The correct nomenclature is identified and reflected for the right and left Hinge Plate Member. The explanation to justify the difference on the approval date between the Manufacturing Process Sheet and the ECO related to the 20mm Hinge Plate was provided. An ECO was included in the response, which reflects the 20mm Hinge Plate with an effective date of 2/5/2009. However, no response was provided for the failure to follow your procedure, Document & Data Control QAP 4.2.3, section 4, i.e. documentation generated by Pega Medical shall pass through the President. No systemic corrective actions were implemented. The response did not identify why the documentation errors existed to begin with or whether other documents within the cited DMR (or other DMRs) were reviewed globally for additional inaccurate documents that may exist.
A follow up inspection will be required to assure that corrections are adequate. We will contact the appropriate people and request an establishment re-inspection. An FDA trip planner will be in touch with you to arrange a mutually convenient date for this inspection.
Your response should be sent to: Matthew C. Krueger, WO66 RM3676 10903 New Hampshire Ave, Silver Spring, MD 20993. If you have any questions about the content of this letter please contact: Kenneth Chen at (301) 796-5595.
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 Observations, 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.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health