FDA Warning Letter to Chinese Manufacturer of OTC Products

Background:

In the recent past, the FDA has reprimanded a number of companies for inadequate control of incoming starting materials. Nevertheless, the FDA regularly publishes further warning letters citing this issue. It is noticeable that inadequate testing, e.g. for ethylene or diethylene glycol impurities, is frequently not the only deficiency found. The companies concerned often exhibit a whole range of other deficiencies.

In the current case, Zhejiang Qimei Cosmetics Co, Ltd, a China-based manufacturer of over-the-counter (OTC) drug products, was inspected by the FDA and rebuked for serious violations of Current Good Manufacturing Practice (CGMP) guidelines. The FDA found that the company's methods, facilities and controls did not meet CGMP requirements, rendering the products adulterated under Section 501(a)(2)(B) of the FD&C Act.

Main violations:

• Inadequate quality control (21 CFR 211.22): The quality unit failed to ensure that sterile IPA prep pads were properly sterilized. In addition, there was a lack of effective monitoring of manufacturing processes.
• Lack of release testing (21 CFR 211.165(a)): Adequate testing for identity and strength of the active ingredient IPA was not performed. Submitted documents such as safety data sheets and certificates of analysis (COAs) by the supplier were not considered sufficient evidence.
• Inadequate testing of components (21 CFR 211.84(d)(1)): Incoming ingredients such as glycerin, propylene glycol, ethanol, and IPA were not adequately tested for hazardous impurities such as diethylene glycol (DEG), ethylene glycol (EG), and methanol. This poses a considerable risk of poisoning.

The FDA strongly recommends that the company engage a qualified CGMP consultant to conduct comprehensive audits and develop corrective actions. Until all violations are corrected, the company remains on Import Alert List 66-40, which restricts imports of its products into the US.

The company has been given 15 working days to respond to the letter in writing, outlining the actions taken and providing a timeline for full correction. Otherwise, the FDA may take further action such as denying importation or rejecting new authorization applications.

Further details are available in the FDA's Warning Letter.