# FDA 483 - International Trading Pharm Lab Inc - October 29, 2019

Source: https://www.globalkeysolutions.net/records/483/international-trading-pharm-lab-inc/55e8c00b-38a4-4328-8111-432524b410e0

> FDA 483 for International Trading Pharm Lab Inc on October 29, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: International Trading Pharm Lab Inc
- Inspection Date: 2019-10-29
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: International Trading Pharm Lab Inc, a control testing laboratory in Paterson, NJ, was cited for significant deficiencies in its quality control and data integrity practices during an FDA inspection. Observations included failures in OOS investigations, inadequate review of analytical data, insufficient computer system controls, and lack of method suitability verification. The firm also lacked proper employee training and equipment maintenance logs, with one observation being a repeat finding.

## Related Documents

- [WARNING_LETTER - 2019-10-29](https://www.globalkeysolutions.net/records/warning_letter/international-trading-pharm-lab-inc/71ceafb9-d248-47b4-abab-dff91020d4f9)
- [483 - 2021-09-16](https://www.globalkeysolutions.net/records/483/international-trading-pharm-lab-inc/ba06956f-e3ab-44bb-aa56-41131a5a1b99)
- [483 - 2023-09-21](https://www.globalkeysolutions.net/records/483/international-trading-pharm-lab-inc/59c8341e-fdec-45a2-b3a9-0e14db4faa15)

## Related Officers

- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.globalkeysolutions.net/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)

Company: https://www.globalkeysolutions.net/companies/international-trading-pharm-lab-inc/87fa021f-89f8-4484-bbdb-d47db12a523b

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248