Fei Fah Medical Manufacturing Pte. Ltd.

Warning LetterOpen

Mr. Lawrence Lau Chief Executive Officer and Owner Fei Fah Medical Manufacturing Pte. Ltd. 61 Kaki Bukit Avenue 1 #02-29 Shun Li Industrial Park 417943 SingaporeFEI 3003892002Issued Jan 30, 2023Center for Drug Evaluation and Research | CDER

View Letter

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 3003892002.

Violations3

Issue DateJan 30, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Fei Fah Medical Manufacturing Pte. Ltd.
Location: Mr. Lawrence Lau Chief Executive Officer and Owner Fei Fah Medical Manufacturing Pte. Ltd. 61 Kaki Bukit Avenue 1 #02-29 Shun Li Industrial Park 417943 Singapore
FEI Number: 3003892002
Country: Singapore
Issue Date: January 30, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Fei Fah Medical Manufacturing Pte. Ltd., a Singapore-based OTC drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company failed to establish and follow adequate written stability testing programs to assess drug product stability characteristics, determine appropriate storage conditions, and assign scientifically supported expiration dates, as required by 21 CFR 211.166(a). Specifically, the firm lacked adequate stability data to support assigned expiration dates for certain drug products and had not established specifications or used stability-indicating methods to test for impurities and degradants. The company's response to the FDA's initial observations was deemed inadequate.

Fei Fah Medical Manufacturing Pte. Ltd. FDA Warning Letter, January 30, 2023