Sunscreen Maker Sent FDA Warning Letter

The US Food and Drug Administration (FDA) has sent a warning letter to Cosmax USA after an inspection of its facility in Solon, OH that was conducted from February 24 to March 17, 2020. 

The agency said it found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (topical sunscreens).  Because the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, the drug products made there are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.
 
FDA said it acknowledged receipt of Cosmax’s letter on April 6, 2020, and its subsequent responses dated May 6 and June 6, 2020.
 
According to FDA, the firm failed 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 company failed to adequately investigate microbial out-of-limit (OOL) results from the system. For example, water sampled on September 30, 2019, yielded an OOL result. Pseudomonas aeruginosa was identified. FDA’s letter stated that Pseudomonas aeruginosa was also found in other samples taken on September 11 and 20, 2019, and despite finding objectionable microbiological contamination in the water system, the firm failed to conduct an adequate investigation.
 
FDA said the firm subsequently found additional water samples to be OOL, including Too Numerous to Count, between September and November 2019. In multiple instances, the company’s investigations did not document the identity of the microorganism(s). 
 
FDA said the company failed to adequately investigate the recurring microbiological failures, and lacked sufficient investigations into poor water quality and its impact on drug product quality.  
 
The company’s response to FDA indicated that other samples collected from before and after the occurrence were within limits and it believes there was no risk to the drug product. FDA said that response is inadequate. FDA also noted that the firm failed to address the root cause of the adverse pattern of excessive and objectionable contamination in your water system. You also did not address any distributed product batches that may be compromised by microbiological contamination.
 
FDA said the company also failed to establish time limits for the completion of each phase of production to assure the quality of the product.
 
Further, FDA said the firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment.