Robert T. Flynn
Chief Executive Officer
Sterling Pharmaceutical Services, LLC
109 S 2nd St.
Dupo , IL 62239
United StatesFEI 3009705561Issued Sep 27, 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 3009705561.
Violations3
Issue DateSep 27, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
Sterling Pharmaceutical Services, LLC
Location
Robert T. Flynn
Chief Executive Officer
Sterling Pharmaceutical Services, LLC
109 S 2nd St.
Dupo , IL 62239
United States
FEI Number
3009705561
Country
United States
Issue Date
September 27, 2022
Issuing Office
Division of Pharmaceutical Quality Operations III
Product Type
Drugs
Status
Open
Summary
Sterling Pharmaceutical Services, LLC, a drug manufacturing facility in Illinois, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their finished pharmaceutical products adulterated. The facility's deficiencies were particularly concerning because many products were ophthalmic drugs intended for use in young children, and the company was also found to be manufacturing unapproved new drugs in violation of federal regulations. The FDA inspection conducted in February 2022 identified multiple specific violations of CGMP regulations governing manufacturing, processing, packing, and holding of drug products.
Sterling Pharmaceutical Services, LLC FDA Warning Letter, September 27, 2022
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