Mr. Bradley M. Rayner
President
Legacy Pharmaceutical Packaging LLC
13333 Lakefront Drive
Earth City , MO 63045
United StatesFEI 3004453700Issued Oct 3, 2022Division of Pharmaceutical Quality Operations III
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 3004453700.
Violations3
Issue DateOct 3, 2022
Product TypeDrugs
StatusClosed
Closeout LetterMay 30, 2024
Letter Details
Firm
Legacy Pharmaceutical Packaging LLC
Location
Mr. Bradley M. Rayner
President
Legacy Pharmaceutical Packaging LLC
13333 Lakefront Drive
Earth City , MO 63045
United States
FEI Number
3004453700
Country
United States
Issue Date
October 03, 2022
Issuing Office
Division of Pharmaceutical Quality Operations III
Product Type
Drugs
Status
Closed
Closeout Letter
May 30, 2024
Summary
Legacy Pharmaceutical Packaging LLC, a drug manufacturing and repackaging facility in Missouri, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an April 2022 FDA inspection. The company failed to thoroughly investigate unexplained discrepancies and batch failures, including a critical failure to adequately investigate foreign tablets found in drug products—a serious concern given that the firm repackages and relabels numerous finished drugs and controlled substances where prevention of mix-ups is paramount. The violations rendered the company's drug products adulterated under federal law due to both non-conforming manufacturing methods and controls, and preparation under insanitary conditions that could result in contamination or health hazards.
Legacy Pharmaceutical Packaging LLC FDA Warning Letter, October 3, 2022