Mr. Stephen T. Fischbach
President and Chief Executive Officer
Safecor Health, LLC
4060 Business Park Drive
Columbus , OH 43204
United StatesFEI 1218914Issued Sep 5, 2023Division of Pharmaceutical Quality Operations I
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1218914.
Violations5
Issue DateSep 5, 2023
Product TypeDrugs
StatusClosed
Closeout LetterFeb 10, 2025
Letter Details
Firm
Safecor Health, LLC
Location
Mr. Stephen T. Fischbach
President and Chief Executive Officer
Safecor Health, LLC
4060 Business Park Drive
Columbus , OH 43204
United States
FEI Number
1218914
Country
United States
Issue Date
September 05, 2023
Issuing Office
Division of Pharmaceutical Quality Operations I
Product Type
Drugs
Status
Closed
Closeout Letter
February 10, 2025
Summary
Safecor Health, LLC, a drug manufacturer and repackager in Woburn, Massachusetts, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered its drug products adulterated. During a March 2023 inspection, FDA investigators found inadequate line clearance procedures on the company's blister packaging equipment, with multiple capsules and tablets from different drugs visibly present on and under the machinery despite documented clearance records, creating a substantial risk of dangerous drug product mix-ups. The firm failed to implement adequate controls to prevent cross-contamination and did not properly inspect packaging facilities before use to ensure removal of materials from previous operations, as required under 21 CFR 211.130(e).
Safecor Health, LLC FDA Warning Letter, September 5, 2023