# FDA 483 - Acino Products, LLC - June 12, 2019

Source: https://www.keypedia.com/records/483/acino-products-llc/25668503-30fe-4bcb-b6a0-eb2f1055107d

> FDA 483 for Acino Products, LLC on June 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acino Products, LLC
- Inspection Date: 2019-06-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Acino Products, LLC in Hamilton, NJ, received a Form FDA 483 with seven observations following an inspection from May 28 to June 12, 2019. The inspection revealed significant deficiencies in quality control, facility maintenance, equipment cleaning, process validation, and laboratory controls, many of which were repeat observations from a previous inspection. These issues indicate a systemic failure to maintain adequate control over drug product manufacturing and quality.

## Related Documents

- [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)
- [483 - 2025-05-21](https://www.keypedia.com/records/483/acino-products-llc/5cf455dc-ed4b-478c-a0de-e90095137f2a)

## Related Officers

- [Russell J. Glapion](https://www.keypedia.com/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

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