FDA Flags Chinese Personal Care Products Maker For Drug GMP Failings
This article was originally published in The Tan Sheet
Executive Summary
The agency will pursue cosmetics and personal care product companies as pharmaceutical manufacturers if their product labeling strays into drug territory. FDA’s warning letter to Shanghai Huhui Daily Use Chemical Products says its skin protectant cream does not comply with the OTC monograph.
FDA liberally draws on its arsenal of enforcement tools in a warning letter to a Chinese personal care products manufacturer, pointing to the firm’s unapproved OTC drug and detailing violations of pharmaceutical good manufacturing practices.
Though Shanghai Huhui Daily Use Chemical Products Co. Ltd. primarily makes cosmetics, detergent, shampoo and skin care products, FDA’s Nov. 14 warning, posted Dec. 4, cites the Shanghai-based company for an unapproved and misbranded skin protectant cream out of compliance with OTC monograph requirements, and proceeds with a litany of drug GMP violations against Huhui.
The letter is the second publicly posted pharmaceutical GMP warning FDA sent to a Chinese personal care product firm in recent months, highlighting an enforcement tactic used relatively rarely in the OTC space.
The agency will pursue cosmetics and personal care product companies as pharmaceutical manufacturers if their product labeling strays into drug territory – especially among foreign firms unfamiliar with the U.S. Food, Drug and Cosmetic Act.
Huhui serves as a contract manufacturer for several Unilever PLC personal care brands, including Dove, Pond’s and Lux. A Unilever spokesman clarified that the skin protectant cream in question is not a Unilever product.
“The safety of our products is a priority for Unilever, and we work closely with all our partners to ensure that the quality control in the manufacturing process of our brands is best in class,” the spokesman said in an email.
Recordkeeping Discrepancies Noted
Huhui’s OTC product in question – the name of which is redacted throughout much of the warning letter, though at one point it is referred to as Nightingale Skin Protectant Cream – is labeled as an occlusive skin protectant cream that “aids in the prevention and treatment of diaper dermatitis (rash)” and “helps protect skin from moisture and wetness.”
Such label language makes the cream a drug not labeled or formulated in accordance with the tentative final monograph for OTC skin protectant drug products, according to the letter from Yanyan (Jenny) Qin, a senior policy advisor in FDA’s Division of International Drug Quality.
Shanghai Huhui’s recordkeeping failures “raise serious concerns regarding the integrity, reliability and traceability of the data generated and documented in your batch production records.”
– FDA
During the agency’s Feb. 6-10 inspection of Huhui’s facility, the company reportedly refused to provide test records for an active pharmaceutical ingredient in the skin protectant product, and inspectors found recordkeeping discrepancies in which the quality control unit recorded batch processing and equipment cleaning operations as occurring at the same time.
Another recordkeeping issue arose when the FDA investigator found opaque correction fluid in many production records for the skin protectant cream, with no notations explaining the changes.
These recordkeeping failures “raise serious concerns regarding the integrity, reliability and traceability of the data generated and documented in your batch production records,” the warning letter says.
Further, Huhui lacked stability data to support temperature storage claims for its skin protectant cream, which was kept in a warehouse with no temperature control, FDA says.
Finally, FDA flagged the firm for not maintaining a current establishment registration or drug product listing with the agency when it was exporting drugs to the U.S. from 2009 through 2012.
FDA Increasing China Capacity, Not Focus
In September, FDA issued a similar warning letter to another Chinese company, Fercy Personal Care Products Co. Ltd., that faulted the firm for terminating the inspection in March before FDA’s investigator could review product records (Also see "Regulatory News In Brief" - Pink Sheet, 24 Sep, 2012.). A hand sanitizer product made by Fercy was the subject of an import refusal report issued in July as a result of the observed GMP violations.
FDA prioritized expanding inspections in China, including requesting $10 million for that purpose in its fiscal 2013 budget (Also see "FDA Needs More Aggressive Globalization Strategy – Sen. Brown" - Pink Sheet, 14 May, 2012.).
A spokesman with the agency’s Center for Drug Evaluation and Research said in an email that FDA has increased the number of OTC drug facility inspections globally but is not targeting China in particular. A facility’s risk level is determined by its compliance history, the types of product produced and the complexity of its processes, not the country, he said.
“FDA has a good working relationship with the State Food and Drug Administration” in China, the spokesman added. “We continue to work with SFDA and to seek additional opportunities to collaborate.”