FDA WARNING_LETTER - Medsource, Inc. - March 31, 2015

The FDA issued a Warning Letter to Medsource, Inc. following an inspection from March 26-31, 2015, which identified significant violations of the Quality System (QS) regulation (21 CFR Part 820) for medical devices, including orthopedic surgical instrument trays. The firm was identified as a manufacturer and distributor of medical devices.

Key violations include: 1. **Failure to control storage areas (21 CFR 820.150(a))**: No procedure for device storage, and observations of orthopedic trays stored next to used trays and a gasoline container. 2. **Failure to establish acceptance activities (21 CFR 820.80(a))**: No acceptance activities for manufacturing or for devices returned for redistribution. 3. **Failure to establish CAPA procedures (21 CFR 820.100(a))**: No procedure for verifying or validating corrective and preventive actions. 4. **Failure to establish management review procedures (21 CFR 820.20)**: No procedures for management review, no quality plan/policy, and no conducted management reviews.

Medsource's April 13, 2015, response to the Form FDA 483 was deemed inadequate, lacking sufficient documentation of corrective actions.

The letter also highlighted that Medsource is considered a manufacturer due to modifying surgical trays, requiring