- Martech Mdi Inc
- Issuing Office:
- Philadelphia District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||PHILADELPHIA DISTRICT|
900 U.S. Customhouse
2nd and Chestnut Streets
Philadalphia, PA 19106
Delivered Via United Parcel Service
April 10, 2015
Mr. Timothy M. Schweikert, President
Martech Medical Products, Inc.
1500 Delp Drive
Harleysville, PA 19438
Dear Mr. Schweikert:
During an inspection of your firm located in Harleysville, Pennsylvania, on February 4, 2015 through February 12, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the (b)(4). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), your (b)(4) 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 (b)(4) 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(b).
Specifically, you did not open a Corrective or Preventive Action (CAPA) to non-conforming complaint events reported with your (b)(4). Complaint reports (b)(4) indicated that the tunneler sleeves were “breaking” and “cracking” in the patients during catheter insertion procedures.
Furthermore, by circumventing your CAPA system, any design change that may have been implemented was not subjected to the rigors of: risk to the patient population, appropriate containment, investigation, corrective action, validation, and effectiveness check, mandated per your CAPA and Recall Management procedures.
2. Lack of or inadequate complaint procedures, as required by 21 CFR 820.198(a)
Specifically, your Complaint Management procedure lacks the essential elements required to evaluate and or escalate complaints that may be reportable as adverse events by you or your specification developers.
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
Acting District Director
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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