14-16 September 2021
The U.S. Food and Drug Administration (FDA) recently published a Warning Letter to a Mexican firm whose facility is registered as a manufacturer of over-the-counter (OTC) drug products in the United States. The Warning Letter is not based on inspection findings from an onsite audit but on the review of documents that the company was required to send at the request of the FDA. The FDA found different serious deficiencies based on the submitted documents.
According to the FDA, the company did not perform adequate incoming testing for components used in the manufacture of the drug products. The company stated that identity testing of active ingredients in some cases consists of evaluating a batch or group of suppliers by collecting random samples. In other cases, identification tests were conducted only based on a sensory evaluation.
Of course, full release testing including strength and identity testing of the active ingredient must be performed prior to drug release and distribution. Nevertheless, based on the documents provided for different lots of one of the OTC drug products, the FDA concluded that the company has not conducted any release testing.
According to the FDA, the documents indicate that the firm lacked an adequate stability testing program to show that the chemical properties of the drug products are acceptable throughout the claimed (labeled) expiry period. For one of the drug products, the samples are not held or tested in the same container-closure system as that in which the drug is marketed, and the active ingredient was not tested at each testing interval.
Finally, the FDA criticizes the lack of an appropriate equipment qualification program. For example, the company responded that an installation qualification and operation qualification documentation for the manufacturing equipment was not implemented. In addition, no calibration information for the equipment, including the scales used to weigh active drug ingredients in the manufacture of the drug products, could be provided.
The FDA already placed all drugs and drug products manufactured by the company on Import Alert 66-40 on November 6, 2020. Based upon the nature of the violations the FDA strongly recommends engaging a consultant to assist the firm in meeting CGMP requirements for drug products.
The complete Warning Letter to Dibar Nutricional S. de R.L. de C.V. can be found on the FDA website.