FDA warns foreign drugmakers over mold, filthy facilities, and other GMP issues
The US Food and Drug Administration (FDA) has released six warning letters to companies in China, India, Malaysia, and France for significant violations of good manufacturing practice (GMP) regulations for finished pharmaceuticals. Among other problems, the letters flag customer complaints about moldy products, unsanitary manufacturing conditions, and lax testing processes.Excelvision Fareva fields mold complaints
FDA sent Excelvision, the Luxembourg-based Fareva subsidiary that makes sterile ophthalmologic products, a warning letter on 7 May outlining failures to meet cleaning standards.
The letter refers to findings of an inspection from 12-19 November 2024 at the company’s facility in Ardeche, France. It acknowledges that the company sent a response on 10 December 2024 to the Form FDA 483, but this was deemed to be inadequate.
According to the letter, the company failed to properly investigate multiple complaints about mold, black specks and discoloration in its sterile prescription and OTC drug products. Instead, FDA charges, the company determined the customers’ handling was at fault and that further action was not necessary. Mold presents serious risks to consumers, especially since the products are sterile and intended for application, as noted in the warning letter.
The letter acknowledges the company’s commitment to cease production of traditional fill lines at the facility and asks for notification of plans to resume manufacturing of products for the US market in the future. The company was given 15 working days to respond to the letter.
Inadequate testing at China facilities
In April, FDA sent warning letters about significant GMP violations to three Chinese companies manufacturing over-the-counter (OTC) products. The letters are similar in some respects, flagging problems with tests of the identify of drug product components and inadequate oversight by quality control units.
Ningbo Riway Industrial Co. was sent a warning letter on 30 April, following an 11 March request for records and other information from the company’s facility in Zhejiang province.
In the letter, FDA charges that the company did not adequately test the identify of incoming components and isopropyl alcohol (IPA) used for manufacturing OTC products, including antimicrobial hand wipes.
“You failed to adequately test your incoming IPA, which is used as an active ingredient for methanol,” FDA wrote. “The use of IPA contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide.”
The agency cited the company for introducing new unapproved and misbranded drugs – Klean Freak body wipes and JJ Care adhesive remover wipes – to the US. Labels indicate they are intended for use as topical antiseptic drug products.
Products were placed under an import alert on 7 November 2024, and the company was given 15 working days to respond in writing to the warning letter.
Shantou S.E.Z. Baojie Industry Co. was sent a warning letter on 15 April, following an inspection of the company’s drug manufacturing facility in Guandong from 26-30 August 2024. The company had submitted a response to the agency’s Form FDA 483, but FDA said that this was inadequate, noting failure to provide sufficient details on how it would ensure adequate identity testing.
“Further, you do not address potential impact on drug products in the U.S. market within expiry,” the agency wrote. “FDA is also concerned that you had committed to corrections previously but did not implement them.”
The firm’s products were placed under import alert on 9 April and a response to the letter was due within 15 working days.
Taizhou Jingshang Cosmetics Technology of Zhejang also received a warning letter on 2 April, following a visit to the company’s drug manufacturing facility from 18-21 November 2024. According to FDA, the company failed to validate and establish the reliability of suppliers’ test analyses at appropriate intervals, creating a risk for hazardous impurities and contaminated ingredients in the final products and lethal poisoning of humans. Furthermore, the agency notes that some of the company’s products may be regulated as cosmetics and should be in compliance with the Federal Food, Drug and Cosmetic (FD&C) Act.
FDA acknowledged the company’s commitment to cease manufacturing and requested corrective actions be completed within 15 working days.
Mentha & Allied Products cited for filthy facility
A 16 April warning letter to Mentha & Allied Products, of Uttar Pradesh, India, flags significant problems with cleaning at the company’s drug manufacturing facility, among other violations.
Violations at the facility were flagged in Form FDA 483 based on an inspection carried out from 16-25 September 2024. FDA said the company’s response was inadequate due to failure to provide enough evidence of corrective actions to bring processes into compliance. Numerous cleaning violations were cited.
“The washroom used by operators was observed to be heavily soiled, and soap for handwashing was not available,” FDA wrote. “In addition, the gowning room was observed to have dirty lockers, garments, and operator shoes.”
The company was given 15 working days to respond in writing and address deficiencies.
BioAsia Worldwide’s GMP fumbles
BioAsia Worldwide, a contract soap manufacturer based in Selangor, Malaysia, received a warning letter outlining significant GMP violations and inadequacies in a response to an inspection from 14-17 October 2024, of a drug manufacturing facility in Sitawan, Perak. The letter acknowledges receipt of a response on 4 November 2024, to its Form FDA 483, but this is inadequate.
Among other things, the warning letter, dated March 25, highlighted failure to conduct tests to verify the identity of drug product components, failure to ensure final specifications for each batch of drug product, and the lack of an adequate written stability testing program and validated manufacturing processes for OTC drug products.
The agency placed an import hold on the company’s products on February 20. A response outlining actions to address deficiencies was due in 15 working days.
Mentha & Allied Products, Taizhou Jingshang Cosmetics Technology, Shantou S.E.Z. Baojie Industry, BioAsia Worldwide, Ningbo Riway Industrial, Excelvision Fareva
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