Medical Components, Inc dba MedComp - Close Out Letter 10/14/15
- Medical Components, Inc dba MedComp
Department of Health and Human Services
|Food and Drug Administration|
|900 U.S . Customhouse|
2nd and Chestnut Streets
Philadelphia, PA 19106
Delivered Via United Parcel Service
October 14, 2015
Medical Components, Inc. dba MedComp
Attn: Timothy M. Schweikert, President
1499 Delp Dr.
Harleysville, PA 19438
Dear Mr. Schweikert:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 15-PHI-12, issued on April 2, 2015. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA
inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Steven L. Carter
Director, Compliance Branch
Philadelphia District Office