FDA WARNING_LETTER - Microbiological Testing & Consulting LLC - September 16, 2025

The FDA issued a warning letter to Microbiological Testing & Consulting, LLC following an inspection from September 8 to 16, 2025, at its Illinois facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations. Because the laboratory"s methods and controls do not meet federal standards, the drug products tested are considered adulterated under the Federal Food, Drug, and Cosmetic Act. The primary issues involve a failure to establish adequate laboratory controls and documentation. The company failed to record essential test details such as equipment numbers, sample sizes, and incubation temperatures. Furthermore, the firm did not properly qualify the media used for microbiological testing, calling into question the reliability of their results. The Quality Unit also failed to exercise proper oversight, particularly regarding the investigation of out-of-specification results. Discrepancies were noted between the records provided to the FDA and those sent to customers, suggesting a lack of transparency and data integrity. Additionally, the laboratory lacked a functional staff training program. To address these violations, the FDA requires a comprehensive, independent assessment of laboratory operations and data integrity. This includes a retrospective three-year review of all test results and media qualifications. The firm must also implement a robust corrective action plan to remediate documentation practices and investigation procedures. The FDA strongly recommends hiring a qualified consultant to assist with these improvements. Failure to correct these issues promptly may lead to legal action, including product seizures or the withholding of drug application approvals.