- Medical Components, Inc dba MedComp
- Issuing Office:
- Philadelphia District Office
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||PHILADELPHIA DISTRICT|
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Delivered Via United Parcel Service
April 02, 2015
Mr. Timothy M. Schweikert, President
Medical Components, Inc.
1499 Delp Drive
Harleysville, PA 19438
Dear Mr. Schweikert:
During an inspection of your firm located in Harleysville, Pennsylvania, on January 13, 2015 through February 12, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the (b)(4) dialysis catheters. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), your (b)(4) dialysis catheters 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 device 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 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. The violations include, but are not limited to, the following:
1. Corrective and preventive action activities and/or results have not been adequately documented, as required by 21 CFR 820.100.
Specifically, two (2) NCRs ((b)(4)) documenting Biological Indicator (BI) failures after ethylene oxide terminal sterilization, revealed that the BI failures issues were not escalated to the CAPA system to determine the root cause of the failures and what corrective actions would be necessary to prevent recurrence of these process failures.
Furthermore, two (2) CAPAs ((b)(4)) found open for over 410 days and have not resulted in a determination of the root cause for on-going performance related problems affecting the (b)(4) dialysis catheters. Thirty-three (33) complaints have been reported to a nonconformance identified as a hole at the lumen to hub junction for the (b)(4) catheters; and twenty-seven (27) complaints pertains to a nonconformance issue reported for the (b)(4) catheters developing holes in the silicone extension tubing.
Finally, CAPAs (b)(4), are open for over 410 days and 409 days respectively, without a determination as to the appropriate corrective actions to prevent Sales personnel from requesting changes to a cleared device design. The product, identified as a (b)(4) catheter, is designed with a cuff. Under a non-approved AMV (authorized manufacturing variance) that was released at Martech Medical Products in Mexico, the design was modified to eliminate the cuff. There was no documentation provided to confirm how the variance was accepted and the change implemented. This resulted in twenty-seven (27) catheters manufactured without any regulatory review and approval of the design change.
2. A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures, as required by 21 CFR 820.75.
Specifically, the Sterigenics Chamber Process Equivalency Final Report, dated 10/22/2009 for the ethylene oxide performance qualification validation conducted on Chamber #2 at Sterigenics in Salt Lake City, Utah, revealed that the chamber had been qualified without any investigation to the significance of "growth" documented in the Biological Indicator (BI) sterility test report, dated 12/15/2009. Additional BI sterility test data, dated 1/22/2010, revealed positive "growth" on five of the seven days under test with each day reporting two positives, yet the results indicated there had been "no growth". Therefore, Sterigenics Chamber #2 used to sterilize your products, is deficient to provide a consistent 10-6 Sterility Assurance Level required by your validation procedure. In addition, the same protocol (VP-SL-006-09) used for the 2009 chamber qualification was also used for a subsequent re-validation conducted in 7/2011 for Chamber # 2, and there was no reference to the previous sterilization failures. Additionally, that the protocol lacks current approval signatures, and lacks a detailed final report documenting the required acceptance criteria are met as defined under section 7.0 of Protocol VP-SL-006-09, Rev 0.
3. Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established., as required by 21 CFR 820.70.
Sterilization documentation from 11 of 45 loads ((b)(4)) that were terminally sterilized in 2014 by ethylene oxide at NASP in Franklin, NJ, revealed that the Pallet Content Log & Process Summary Report form did not define all current sterilization validated process parameters. As a result, the regulatory review as required by Section 6.0 of QA-1-400 (Sterile Product Release for Distribution Procedure) cannot be fully assessed as part of the acceptable release for these loads.
We have received your written response, dated March 6, 2015, and your representations in your letter concerning your corrective actions to the observations noted on the Form FDA 483, List of Inspectional Observations. While we recognize your attempts to achieve voluntary compliance, your corrective actions cannot be fully evaluated until you are able to demonstrate to the FDA, during the next inspection at your facility, that these corrective actions are implemented and followed, and are sufficient to maintain a state of control with respect to the Quality System Regulation.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to correct these violations promptly may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may consider this information when considering the award of contracts.
Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as 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 actions (including any systemic corrective actions) 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. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your written response should be sent to Joseph A. Morkunas, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Mr. Morkunas at (215) 717-3079 or e-mail at Joseph.Morkunas@fda.hhs.gov.
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 Inspectional 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.
Anne E. Johnson
cc: Pennsylvania State Department of Health
132 Kline Plaza, Suite A Harrisburg, PA 17104
Attention: Director, Division of Primary Care and Home Health Services
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