Aire-Master of America, Inc.

Warning LetterOpen

United StatesFEI 3002764676Issued May 23, 2022Division of Pharmaceutical Quality Operations III

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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 3002764676.

Violations0

Issue DateMay 23, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Aire-Master of America, Inc.
Location: United States
FEI Number: 3002764676
Country: United States
Issue Date: May 23, 2022
Issuing Office: Division of Pharmaceutical Quality Operations III
Product Type: Drugs
Status: Open

Summary

Aire-Master of America, Inc. received an FDA Warning Letter in May 2022 regarding adulterated drug products manufactured in violation of Current Good Manufacturing Practice (CGMP) standards. Based on the limited metadata available, the company appears to have failed to maintain adequate manufacturing controls or quality systems for finished pharmaceuticals. The warning was issued by the FDA's Division of Pharmaceutical Quality Operations III, indicating the agency identified significant compliance gaps in the company's pharmaceutical manufacturing operations.

Aire-Master of America, Inc. FDA Warning Letter, May 23, 2022