FDA Issues Warning Letter To FLA Skin Care Firm

Trilogy Laboratories, LLC, Fort Meyers, FL, has received a warning letter from the US FDA following an inspection at its site in August 2019 in which the agency found .significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in drug products that are adulterated as indicted in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
 
Additionally, FDA says the firm manufactures, repackages, distributes or sells products that are  unapproved new drugs (AZUL Gly Sal Pads, AZUL Acne Defense Cream, and Azul DermaBright HQ Serum), and manufactures, repackages, distributes or sells AZUL Satin Eclipse Broad Spectrum SPF 32 which is misbranded. Introduction or delivery for introduction of  these products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C.
 
The FDA said it reviewed the company’s September 18, 2019  response but said it was inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP. Specifically, FDA said the firm’s response did not address the effect of these violations on the quality of its over the counter (OTC) drug products currently on the US market and within expiry. 
 
Among the CGMP violations were failure to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and conduct appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms; failure to conduct at least one test to verify the identity of each component of a drug product and failure to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals; failure to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.
 
FDA also cited unapproved new drug and misbranding violations cited for products that were intended for use for acne and suncare. 
 
The agency also took issue with website labeling claims as well.
 
The full details can be found here.