# FDA 483 - International Trading Pharm Lab Inc - September 21, 2023

Source: https://www.keypedia.com/records/483/international-trading-pharm-lab-inc/59c8341e-fdec-45a2-b3a9-0e14db4faa15

> FDA 483 for International Trading Pharm Lab Inc on September 21, 2023. 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: 2023-09-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: International Trading Pharm Lab Inc, a control testing lab in Paterson, NJ, was cited for significant deficiencies in laboratory controls and data integrity during an FDA inspection. Observations included inadequate method verification, insufficient computer system controls with broad administrator access, failure to investigate discrepancies, and non-functional data loggers for stability monitoring. These issues indicate a lack of assurance in the quality and reliability of drug product testing and data.

## 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 - 2021-09-16](https://www.keypedia.com/records/483/international-trading-pharm-lab-inc/ba06956f-e3ab-44bb-aa56-41131a5a1b99)

## Related Officers

- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [Stephenie M. Ortiz](https://www.keypedia.com/people/stephenie-m-ortiz/b0923b14-b153-4893-8eb2-f5e6b1fd2041)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

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