Tec Laboratories Inc – FDA Warning Letter, Jul 13, 2018

The FDA inspected Tec Laboratories, Inc. from July 9-13, 2018, identifying significant CGMP violations, rendering their drug products adulterated. The product "CALAGEL" was also deemed an unapproved new drug.

Violations include: 1. **Failure to conduct appropriate laboratory testing (21 CFR 211.165(b))**: The firm released topical OTC and homeopathic drug products (e.g., LiceFreee Spray! Head Lice Treatment, Calagel First Aid Antiseptic) intended for use on broken skin without testing for objectionable microorganisms. The firm's response was inadequate as it lacked verification studies for the USP method used and data for previously released products. The FDA requires test results for all previously released batches within 60 days, including analytical records and lab information. Out-of-specification results require customer notification and recalls.

2. **Failure to thoroughly investigate discrepancies (21 CFR 211.192)**: The firm failed to investigate an out-of-limit result for the purified water system on February 5, 2018, and did not evaluate the impact on drug products manufactured between December 27, 2017, and February 5, 2018. The firm's response did not adequately address potential risks from microbiological contamination.

Additionally, "CALAGEL" is an unapproved new drug (