# FDA 483 - Garonit Pharmaceutical, Inc. - July 06, 2023

Source: https://www.globalkeysolutions.net/records/483/garonit-pharmaceutical-inc/995c75ff-b43f-4748-a440-b71b13da4fb0

> FDA 483 for Garonit Pharmaceutical, Inc. on July 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Garonit Pharmaceutical, Inc.
- Inspection Date: 2023-07-06
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Garon Pharmaceutical Inc., an API manufacturer in Fairfield, NJ, was cited with two observations during an FDA inspection. The firm failed to extend investigations to other potentially affected batches following a contamination complaint and demonstrated deficiencies in documenting and investigating deviations. These issues indicate weaknesses in the firm's quality system regarding complaint handling and deviation management.

## Related Documents

- [483 - 2020-10-20](https://www.globalkeysolutions.net/records/483/garonit-pharmaceutical-inc/6a834108-7ef3-4377-a2a9-c2d66e407d92)
- [EIR - 2023-07-06](https://www.globalkeysolutions.net/records/eir/garonit-pharmaceutical-inc/40f560e8-cb0e-46bb-bff2-9557ac414f4f)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)

Company: https://www.globalkeysolutions.net/companies/garonit-pharmaceutical-inc/a1d49be9-6558-4320-a2e9-5cc74fe7d45d

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