FDA Issues Repeat Warning Letter to Thailand-Based OTC and Cosmetics Manufacturer, International Laboratories

The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm’s Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and distributor of Cosmetics and OTC products.

Key Findings:

• Fabrication of Laboratory Records: The Quality Control Unit fabricated laboratory records and investigations that were not performed.
• Data Integrity Concerns:
  • Failure to retain original data from analytical testing of raw materials and finished products.
  • Lack of control over laboratory equipment and computerized systems.
  • Numerous electronic records were deleted, and analysts had administrator rights to alter or delete chromatographic data.
  • Several electronic results were missing and unavailable for review.
• Quality Unit Oversight: The Quality Unit (QU) could not provide records to support cGMP requirements for product testing, stability studies, data review, and batch records and failed to ensure oversight over the manufacture of the products
• Systemic Weaknesses: The overall quality system did not ensure the accuracy and integrity of data to safety and quality of the drugs manufactured.

This is the second Warning letter issued to the site. Earlier in August 2023, ILC was issued a Warning letter by after review of the documents submitted. The deficiencies included failure to test incoming components used in manufacture of products and failure of the quality unit (QU) to oversee quality of drug manufacturing operations. Following this, the FDA placed International Laboratories Corp. under Import Alert 66-40. The firm remains on this import alert due to continued compliance failures.

Key Takeaways:

Certain cosmetics with therapeutic claims or those intended to affect body structure or function—such as anti-dandruff shampoos, sunscreens, acne treatments, and hair regrowth products—fall under the OTC drug category in the U.S. These products are subject to CGMPs outlined in 21 CFR 210 and 211. Manufacturers offering such products in the U.S. must ensure compliance with CGMP requirements for manufacture of drug products.

References:

• USFDA Warning Letter to International Laboratories Corp (March, 2025)
• USFDA Warning Letter to International Laboratories Corp (August, 2023)
• USFDA’s Cosmetics Guidance & Regulation: Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)