The warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
The inspection was conducted from July 8 to 12, 2019, according to the agency.
During its inspection, FDA investigators observed specific violations including failture to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
According to FDA, the facility did not adequately investigate the out-of-specification (OOS) microbiological contamination that caused it to reject select batches of its OTC drug product, including results as high as (b)(4) CFU/g. According to FDA, while the company documented these OOS results in an annual product review, it failed to conduct an adequate investigation to prevent recurrence or microbial contamination in the drug products it manufactured for the US market. FDA also said that the firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR
Additionally, FDA said the firm failed to establish adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
According to FDA, failure to correct these violations may also result in the FDA refusing admission of articles manufactured at Baja Fur S.A. de C.V. into the US under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
Additional details can be accessed here.