# FDA 483 - International Laboratories Corp - September 20, 2024

Source: https://www.keypedia.com/records/483/international-laboratories-corp/bedd5d48-11e0-4b26-a96c-05c460da5dde

> FDA 483 for International Laboratories Corp on September 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: International Laboratories Corp
- Inspection Date: 2024-09-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: International Laboratories Corp, an OTC drug manufacturer in Bang Phli, Thailand, was cited for severe data integrity and quality control deficiencies during an FDA inspection. Observations included fabricated and backdated OOS investigations, lack of complete laboratory records and data traceability, and inadequate controls over computer systems and master records. The firm also failed to establish essential written procedures for production, process controls, and quality unit responsibilities.

## Related Documents

- [WARNING_LETTER - 2024-09-20](https://www.keypedia.com/records/warning_letter/international-laboratories-corp/41a0cd4c-6992-49b9-b403-4d66876e77de)

## Related Officers

- [Samantha E. Cleek](https://www.keypedia.com/people/samantha-e-cleek/7305f28f-9c92-427d-86ec-42c0bb6bf3ce)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.keypedia.com/companies/international-laboratories-corp/9356b6f5-3a04-4e5a-886a-e48d324e0e0f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8