# FDA 483 - International Trading Pharm Lab Inc - September 16, 2021

Source: https://www.keypedia.com/records/483/international-trading-pharm-lab-inc/ba06956f-e3ab-44bb-aa56-41131a5a1b99

> FDA 483 for International Trading Pharm Lab Inc on September 16, 2021. 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: 2021-09-16
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of International Trading Pharm Lab Inc. in Paterson, NJ, revealed significant deficiencies in their control testing laboratory. The firm failed to thoroughly investigate out-of-specification results and lacked scientifically sound test procedures for assuring drug product quality. These issues indicate a serious breakdown in quality control and data integrity within their analytical operations.

## Related Documents

- [483 - 2019-10-29](https://www.keypedia.com/records/483/international-trading-pharm-lab-inc/55e8c00b-38a4-4328-8111-432524b410e0)
- [WARNING_LETTER - 2019-10-29](https://www.keypedia.com/records/warning_letter/international-trading-pharm-lab-inc/71ceafb9-d248-47b4-abab-dff91020d4f9)
- [483 - 2023-09-21](https://www.keypedia.com/records/483/international-trading-pharm-lab-inc/59c8341e-fdec-45a2-b3a9-0e14db4faa15)

## Related Officers

- [Jay B. Shah, Investigator](https://www.keypedia.com/people/jay-b-shah-investigator/ca493486-0f92-4d7f-bf52-2f5ad9c294c2)
- [Lata C. Mathew, Ph.D., Investigator](https://www.keypedia.com/people/lata-c-mathew-phd-investigator/f0682266-2ed3-4fd5-b64d-62944651792c)

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

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