# FDA 483 - Acino Products, LLC - May 21, 2025

Source: https://www.keypedia.com/records/483/acino-products-llc/5cf455dc-ed4b-478c-a0de-e90095137f2a

> FDA 483 for Acino Products, LLC on May 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acino Products, LLC
- Inspection Date: 2025-05-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Acino Products, LLC in Hamilton, NJ, an OTC finished drug product distributor, revealed significant deficiencies. The firm failed to maintain adequate environmental controls for drug product storage in a residential garage, lacked scientific data to support expiration dates, and did not have a written quality control unit procedure for handling complaints. These issues include repeat observations from previous inspections.

## Related Documents

- [483 - 2019-06-12](https://www.keypedia.com/records/483/acino-products-llc/25668503-30fe-4bcb-b6a0-eb2f1055107d)
- [WARNING_LETTER - 2019-06-12](https://www.keypedia.com/records/warning_letter/acino-products-llc/0898b57a-556a-4d21-a138-4107c08980d7)
- [483 - 2021-07-01](https://www.keypedia.com/records/483/acino-products-llc/9a772c5e-1b86-435c-8d9f-356366992be3)
- [483 - 2024-08-30](https://www.keypedia.com/records/483/acino-products-llc/a8a662a1-7504-4fd5-a242-ba157073cad9)

## Related Officers

- [Suchan Kim](https://www.keypedia.com/people/suchan-kim/1acf9a36-036f-48a8-a8a4-caa290830e37)
- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.keypedia.com/companies/acino-products-llc/8499d0c9-9cf4-432b-96dd-6e7c087fa70f

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