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

Source: https://www.globalkeysolutions.net/records/warning_letter/international-laboratories-corp-ltd/7ef91665-045f-46fb-9202-abcc24dc7d3d

> FDA WARNING_LETTER for International Laboratories Corp. Ltd. on August 08, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: International Laboratories Corp. Ltd.
- Inspection Date: 2023-08-08
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Manoj Zacharias](https://www.globalkeysolutions.net/people/manoj-zacharias/48c7f45d-c17d-4016-b4d5-fbcbfd39bf6a)

Company: https://www.globalkeysolutions.net/companies/international-laboratories-corp-ltd/37f28d1b-9425-4819-ab2c-03be6cf13fc1

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c