FDA WARNING_LETTER - Midlab Incorporated - August 05, 2022

The FDA inspected Midlab Incorporated's drug manufacturing facility from August 1-5, 2022, revealing significant Current Good Manufacturing Practice (CGMP) violations, rendering drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's August 26, 2022, response was deemed inadequate. Key CGMP deficiencies include: failure to conduct appropriate microbial testing for each batch of drug product (21 CFR 211.165(b)); failure to thoroughly investigate out-of-specification (OOS) results and to quarantine/reject expired raw materials (21 CFR 211.192); inadequate quality control unit oversight (21 CFR 211.22); and failure to establish adequate written procedures for production and process control, including process and water system validation (21 CFR 211.100(a)). Additionally, "MAXIM Instant Foam Hand Sanitizer" is an unapproved new drug (21 U.S.C. 355(a)) as it's not Generally Recognized as Safe and Effective (GRASE) and makes specific pathogen claims. It is also misbranded under 21 U.S.C. 352(ee) for non-compliance with 505G requirements. "MAXIM Antibacterial Foam Soap FDF," "MAXIM Antibacterial Hand Soap," and "MAXIM Assure Antibacterial" are misbranded (21 U.S.C. 352(c)) due to incorrect active ingredient naming ("PCMX" instead of "chloroxylenol") and dual language labeling lacking Spanish net quantity of contents (21 CFR 201.15). The FDA recommends engaging a qualified CGMP consultant for a comprehensive audit. Failure to address these violations may lead to regulatory actions, including seizure, injunction, and withholding of export certificates or application approvals. A detailed corrective action plan is required within 15 working days.