Kobayashi Healthcare International, Inc. – FDA Warning Letter, May 27, 2022

The FDA inspected Kobayashi America Manufacturing, LLC, from May 23-27, 2022, identifying significant CGMP violations, rendering their drug products adulterated. The "ZIM’S HYDRO COOLING PAIN RELIEF PATCH" was also cited as an unapproved new drug and misbranded.

Violations included failure to conduct microbiological testing for OTC drug products like Zim’s Max Freeze Gel, Roll-on, and Liquid, despite the Quality Assurance Director stating it wasn't part of release testing. The firm's claim of no microbial danger due to alcohol content was deemed inadequate, lacking scientific basis and retrospective testing. The FDA requires an action plan, timelines for full microbiological testing of retain samples, and a summary of results, with potential recalls for substandard products.

Additionally, the firm's quality control unit failed to ensure CGMP compliance and meet specifications (21 CFR 211.22), lacking adequate procedures and oversight. The FDA requires a determination of robust procedures, provisions for QU oversight, complete batch review before disposition, and approval of investigations. The FDA recommends engaging a consultant to address these systemic quality system deficiencies.

The "ZIM’S HYDRO COOLING PAIN RELIEF PATCH" is an unapproved new drug because its active ingredients (lidocaine 4%, menthol 1%) and labeling claims do not conform to the External Analgesic Drug Products TFM. Lidocaine is not an approved counterirritant