FDA WARNING_LETTER - International Laboratories Corp. Ltd. - August 08, 2023

This FDA Warning Letter (320-23-34), dated August 8, 2023, addresses International Laboratories Corp. Ltd. (FEI 3006403166) in Thailand, an OTC drug product manufacturer. The letter stems from a review of records submitted in response to a March 17, 2023, Section 704(a)(4) request.

The FDA identified significant Current Good Manufacturing Practice (CGMP) violations, rendering the firm's drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include:

1. **Failure to conduct identity testing for drug components (21 CFR 211.84(d)(1)):** The firm did not adequately test each shipment of high-risk incoming components, such as (b)(4) and (b)(4), for identity, including USP limit tests for (b)(4) or (b)(4) contamination. This failure compromises the acceptability of components for drug manufacturing.

2. **Inadequate Quality Control Unit (QCU) (21 CFR 211.22(a)):** The QCU failed to effectively oversee drug manufacturing operations, specifically in approving or rejecting components in the Materials System. Concerns were raised about potential lack of oversight in Production, Facilities & Equipment, Laboratory Controls