The warning letter, dated June 12, 2019, came in response to earlier correspondence between the two and summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, 21 CFR parts 210 and 211, according to FDA.
FDA said that because the company’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, its drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
During FDA inspection, investigators observed specific violations including, but not limited to, 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 for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and (b)). Products included Naawk Aloe Relief Gel + Lidocaine, Unscented SPF 30 Sunscreen Lotion, and Coconut Breeze SPF 50 Fill without adequate testing for identity and strength of the active ingredients. In addition, FDA said SnugZ also released finished drug products without adequate testing for critical microbial attributes.
FDA has requested that the company provide:
• Procedures for testing all finished drug dosage products according to your firm’s specifications.
• Completed chemical and microbial analytical method validation, equipment validation, and updated test methods. Also provide specifications that your drug products must conform to before a batch disposition decision.
• A summary of test results obtained from testing retain samples of all drug products within expiry that have been distributed in the United States. These test results should include identity and strength of active ingredients and all other appropriate quality attributes.
In addition, FDA contends the company failedto adequately test incoming active pharmaceutical ingredients (API) and other raw materials used in manufacturing your drug products to determine the conformance to identity, purity, strength, and other specifications. Instead, your firm released API and other materials based on the certificate of analysis (COA) from your supplier without establishing the reliability of the supplier’s analysis through appropriate validation and ensuring at least one specific identity test is conducted for each lot.
FDA said the firm also lacked an adequate quality unit (QU) and failed 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 (21 CFR 211.100(a)).
Lastly, FDA said the firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
For example, FDA said the investigator observed that filling equipment used to manufacture OTC drug products was filthy and contained drug product residues.
FDA said that in its reponse, SnugZ acknowledged the significance of the CGMP observations. However, FDA said the company “provided limited corrective actions and insufficient details and evidence to support that your proposed corrective actions will bring your operations and distributed drug products into full compliance with CGMP.:
SnugZ had 15 days after receipt the June letter, respond to FDA.