The FDA has banned products from an Australian company's plant in Guangzhou, China, and cited it with “significant violations” of cGMP regulations saying that it did not do enough to test its active ingredients and products before they were shipped to the U.S.
The Ausmetics Daily Chemicals plant was founded solely by Australian investments in 1998, and according to the company’s website, it is an OEM and ODM manufacturer, whose products include hygiene washes, ointments for breastfeeding mothers and an eczema treatment. It counts among its customers, Tesco, K-mart and Dollar Tree. It says it obtained a certificate of good manufacturing practice for cosmetics from the U.S. FDA in 2009.
However, after an inspection in July, the FDA sent it a warning letter on Jan. 31 saying that the company was in violations of cGMP regulations which could have compromised its drug products. The FDA posted the letter this month.
According to the company’s Sep. 28, 2016, correspondence with the agency, as quoted by the warning letter, the company has “ceased the export to the U.S.,” and therefore does not plan to rectify those violations as mandated by U.S. regulations.
The FDA said if it ever plans to resume manufacturing drugs for the U.S. market, it should seek help from a qualified consultant. The agency also placed an import alert on the company starting from Dec. 20, 2016, and will not approve any new products listing Ausmetics as a drug manufacturer until it can confirm the company’s total compliance with cGMP.
Among the issues that must be resolved, the FDA said, was its failure to test enough batches of products for identity, strength or existence of microorganisms was on top of the FDA’s findings.
The warning letter also said it appeared the firm was making up expiration dates for its products since those dates didn’t have any supporting stability studies. Besides, the company’s approach to component identification was also far from rigorous. The agency’s inspection found the company accepted and used active raw materials simply by their appearance and odor.
Moreover, the FDA also found the company didn’t keep complete production and control records for each batch of drug product produced. Without that information, the FDA said it’s hard to determine that the materials and final product actually meets quality requirements.
According to the company’s website, it has worked with big companies like Mannings, Watsons, Tesco, H&M and IKEA and has a large collection of cosmetics and body care products for pregnant women, infants and men for usage on face, body and hair, plus some appliances and clothing cleaning products.