Tuesday, 19 January 2021 14.00 - 15.30 h
From September 26 to September 29, the US FDA published four Warning Letters. One company is located in China and the other three are based in Europe.
The Warning Letter sent to Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. in China is related to finished pharmaceuticals. The company located in Yangzhou, Jiangsu has been placed on Import Alert and will not be able to deliver products to the US. The Warning Letter states that FDA has performed own tests of the products manufactured by the company. The test revealed that certain products did not contain any of the labeled active ingredients. An inspection performed by FDA already in 2015 found that not all products released had been tested. The FDA requires comprehensive CAPA activities and also strongly recommends engaging a consultant to meet the cGMP requirements.
The second Warning Letter was sent to Laboratoire Sintyl S.A. in Geneva, Switzerland. A four-days inspection by FDA was performed in June 2016. In total, the investigators detected six critical deviations. Among others the company had no independent quality unit, and cleaning and maintenance of the equipment. Also, there was no process validation procedure in place. Here again, FDA has recommended to hire a consultant.
On September 29, the FDA issued a Warning Letter to the UK-based company Wallace Cameron International Ltd. in Wishaw Scotland. The company has "not fulfilled the establishment registration and drug listing obligations under the Federal Food, Drug, and Cosmetic Act (the Act)".
Delarange Cosmetics & Healthcare BV in Zeewolde, The Netherlands received a Warning Letter on September 29 as well. The Warning Letter followed an inspection performed from May 30 to June 3, 2016. The company had to admit to have no independent quality unit and had failed to have adequate cleaning procedures of the equimpent to avoid cross contaminations.