FDA Sends Warning Letter To Contract Filler

The US Food & Drug Administration (FDA) sent a warning letter on Dec. 17, 2019 to Cross Brands Contract Filling, LLC, Rockledge, FL, following an inspection conducted at its facility in June 2019. The warning letter summarizes what FDA calls “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.”
 
During the inspection, an FDA investigator observed specific violations including, failure to conduct at least one test to verify the identity of each component of a drug product. FDA said that the firm also failed to validate and establish the reliability of its component supplier's test analyses at appropriate intervals.
 
Cross Brands Contract Filling manufactures over-the-counter (OTC) sunscreens (e.g., “Sea and Ski) and contract manufactures OTC topical salicylic acid-containing products. 
 
During the inspection, FDA said it observed that the firm did not perform testing on the components used in manufacture.  While the company’s management explained to the agency that raw materials are received from vendors with the certificates of analysis (COA) which indicate the results for each lot, FDA noted that it is required to verify the identity of each component used in the manufacture of its drug products. Additionally, FDA’s letter stated that the CM must test each component for conformity with appropriate written specifications for purity, strength, and quality unless and until you have appropriately qualified the suppliers and validated their test results at appropriate intervals. FDA said that the company lacks specificity regarding its validation program. Additionally, FDA said the company’s response did not address retrospective identity testing to assess the quality of components used in the manufacture of drug products distributed within expiry.
 
FDA said it also observed that the company’s quality unit (QU) did not provide adequate oversight over the manufacture of the drug products. For example, there was a lack of adequate written procedures describing manufacturing operations and failure to ensure that all batch and laboratory records are complete.
 
FDA said its inspection found that the firm’s QU misrepresented results for the absence of Staphylococcus aureus and Pseudomonas aeruginosa on COA that were released to customers. 
 
During the inspection, FDA said it also discovered that the firm did not have an established monitoring program for microbiological quality of the water used as a component in the production of topical drug products.
 
In addition, FDA issued Unapproved New Drug charges for several products (Including facial cleansers,  body washes and shampoos) based on examples of claims observed on the product labels and website. FDA took issue with statements that appeared on website’s customer reviews page. 
 
The full letter can be accessed here.