Daniel Ramirez, General Manager
Dylan Kim, Vice President of R&D
CTK OTC Laboratories LLC formerly FMK LABS, Inc.
1690 N. Delilah Street
Corona , CA 92879
United StatesFEI 3014253278Issued May 19, 2025Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3014253278.
Violations4
Issue DateMay 19, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
CTK OTC Laboratories LLC formerly FMK LABS, Inc.
Location
Daniel Ramirez, General Manager
Dylan Kim, Vice President of R&D
CTK OTC Laboratories LLC formerly FMK LABS, Inc.
1690 N. Delilah Street
Corona , CA 92879
United States
FEI Number
3014253278
Country
United States
Issue Date
May 19, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
CTK OTC Laboratories LLC (formerly FMK LABS, Inc.) was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs. During a December 2024 inspection, the FDA found that the company failed to adequately investigate out-of-specification (OOS) results, including a bulk base batch with low potency that was corrected through re-mixing and API addition without determining the root cause, and subsequently experienced high viscosity issues that were not properly investigated. These manufacturing deficiencies rendered the drug products adulterated under federal law, as the company's methods, facilities, and controls did not conform to CGMP regulations.
CTK OTC Laboratories LLC formerly FMK LABS, Inc. FDA Warning Letter, May 19, 2025
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