Raymundo Osuna
Vice President of Operations
Quality Supplement Manufacturing, Inc.
300 N. Macarthur Blvd
Oklahoma City , OK 73127
United StatesFEI 3011606714Issued Dec 13, 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 3011606714.
Violations14
Issue DateDec 13, 2022
Product TypeDietary Supplements
StatusOpen
Letter Details
Firm
Quality Supplement Manufacturing, Inc.
Location
Raymundo Osuna
Vice President of Operations
Quality Supplement Manufacturing, Inc.
300 N. Macarthur Blvd
Oklahoma City , OK 73127
United States
FEI Number
3011606714
Country
United States
Issue Date
December 13, 2022
Issuing Office
Division of Pharmaceutical Quality Operations III
Product Type
Dietary Supplements
Status
Open
Summary
Quality Supplement Manufacturing, Inc. received a warning for adulterated dietary supplements that failed to comply with Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Part 111. During a June 2022 inspection, the FDA identified serious violations including the company's failure to establish adequate product specifications for identity and purity of finished batches, specifically noting deficiencies in specifications for multiple dietary supplement products. The violations indicated that the company's products were prepared, packed, or held under conditions that did not meet federal CGMP requirements, rendering them adulterated under the Federal Food, Drug, and Cosmetic Act.
Quality Supplement Manufacturing, Inc. FDA Warning Letter, December 13, 2022
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