# FDA 483 - Acino Products, LLC - August 30, 2024

Source: https://www.globalkeysolutions.net/records/483/acino-products-llc/a8a662a1-7504-4fd5-a242-ba157073cad9

> FDA 483 for Acino Products, LLC on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acino Products, LLC
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Acino Products, LLC, a drug manufacturer in Trenton, NJ, was inspected and found to have significant deficiencies across its operations. The inspection revealed a severe lack of validated processes, inadequate quality control procedures, unsanitary conditions in a residential garage used for drug packaging and storage, and insufficient testing for product stability and microbial contamination. Many of these issues were repeat observations from previous inspections, indicating a systemic failure to adhere to GMP regulations.

## Related Documents

- [483 - 2019-06-12](https://www.globalkeysolutions.net/records/483/acino-products-llc/25668503-30fe-4bcb-b6a0-eb2f1055107d)
- [WARNING_LETTER - 2019-06-12](https://www.globalkeysolutions.net/records/warning_letter/acino-products-llc/0898b57a-556a-4d21-a138-4107c08980d7)
- [483 - 2021-07-01](https://www.globalkeysolutions.net/records/483/acino-products-llc/9a772c5e-1b86-435c-8d9f-356366992be3)
- [483 - 2025-05-21](https://www.globalkeysolutions.net/records/483/acino-products-llc/5cf455dc-ed4b-478c-a0de-e90095137f2a)

## Related Officers

- [Suchan Kim](https://www.globalkeysolutions.net/people/suchan-kim/1acf9a36-036f-48a8-a8a4-caa290830e37)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [issuing_officer](https://www.globalkeysolutions.net/people/catherine-o-lamptey/9ddfa564-70b7-4a8b-9209-9d21205ebf60)

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

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