The U.S. Food and Drug Administration (FDA) has sent six warning letters to drug manufacturing firms in India, China, France, and Malaysia for severe violations of Good Manufacturing Practices (GMP). The infractions comprise mold contamination, unclean conditions, poor testing, and neglect to correct shortcomings indicated in previous inspections.

Key highlights India:

Mentha & Allied products flagged for filthy conditions

• The Uttar Pradesh-based firm was charged with dirty operator washrooms, soap missing, dirty lockers, and operator footwear at the plant.

• FDA has found their reply to previous Form 483 findings lacking and asked for a 15 working day correction plan.

France: Excelvision Fareva cited over mold in sterile products

• The Luxembourg-based subsidiary of Fareva was unable to respond to several complaints of mold and black specks in sterile ophthalmic products.

• It has received FDA's Form 483 in November 2024 and replied in December but the regulator found the response inadequate.

• FDA has required reports on plans for resuming U.S. market production.

China: Three manufacturers under scrutiny

• Ningbo Riway Industrial Co. was cited for not testing incoming isopropyl alcohol (IPA) for methanol contamination—associated with deadly poisonings.

• Shantou S.E.Z. Baojie Industry Co. was cautioned for insufficient identity testing and failure to follow through on prior corrective actions.

• Taizhou Jingshang Cosmetics Technology did not verify test results from suppliers and correct contamination hazards. Certain of its products could be categorized under U.S. cosmetic regulations.

Malaysia: BioAsia worldwide cited for multiple GMP failures

• FDA noted the absence of final batch testing, validated processes, and stability testing programs at the firm's facility in Selangor.

• Products from the facility are presently under import alert as of February 2025.

Regulatory enforcement and global compliance

• Several products from these companies have been placed under import alert by FDA, preventing their entry into the U.S. market.

• The companies were provided with 15 working days to respond with specific corrective measures to prevent further enforcement.

The FDA's recent series of warning letters underscores its worldwide vigilance in maintaining manufacturing quality standards. Indian and foreign drugmakers now need to intensify compliance with GMP guidelines to ensure patient safety and maintain access to regulated markets such as the United States.