# FDA 483 - Health Pharma USA LLC - September 22, 2021

Source: https://www.globalkeysolutions.net/records/483/health-pharma-usa-llc/ab32da9f-e10a-4cef-bbb3-dbfad08ebda2

> FDA 483 for Health Pharma USA LLC on September 22, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Pharma USA LLC
- Inspection Date: 2021-09-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Health Pharma USA LLC in Rahway, NJ, revealed significant deficiencies in laboratory controls, quality systems, production, and packaging. The firm failed to qualify working standards, maintain proper computer system controls, calibrate equipment, and adequately document laboratory and batch records. These issues indicate a lack of adherence to good manufacturing practices for drug products.

## Related Documents

- [WARNING_LETTER - 2019-06-03](https://www.globalkeysolutions.net/records/warning_letter/health-pharma-usa-llc/c266f585-927f-44ae-8303-d1cca43b446f)
- [483 - 2022-12-20](https://www.globalkeysolutions.net/records/483/health-pharma-usa-llc/782420cb-4cd0-4ad6-9fef-afa29634fb72)
- [483 - 2024-07-03](https://www.globalkeysolutions.net/records/483/health-pharma-usa-llc/f16a7c65-46fd-484e-b683-8153a44026e3)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)
- [investigator](https://www.globalkeysolutions.net/people/monika-borkowska/4dedee7d-7b93-4f1b-be3b-17ab41e5c0ff)

Company: https://www.globalkeysolutions.net/companies/health-pharma-usa-llc/6c32dbbf-80d6-4e1a-b850-dfd78b2e0117

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