Acino Products, LLC
FDA inspection history in Hamilton, New Jersey, 2019 to 2025
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one Form 483; 2020: one close-out letter; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20One Form 483 and one close-out letter, at Hamilton, New Jersey.
- 2019The longest 483 on file: 7 observations over 5 pages at Hamilton, New Jersey.
- 2025One Form 483, at Hamilton, New Jersey.
Cited most
Across all Acino Products observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166(b)Stability testing1
The complete Acino Products file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Hamilton, New Jersey
Two Form 483s and one close-out letter · 2019 to 2025 · 10 observations
Latest: Form 483, May 21, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-21 | 483 Form 483 | Hamilton, New Jersey | 3 | $99 |
| 2020-02-10 | Close-out Close-out letter | Hamilton, New Jersey | — | $99 |
| 2019-06-12 | 483 Form 483 | Hamilton, New Jersey | 7 | $99 |
Investigators on these documents
James R. Birkenstamm (1)Russell J. Glapion (1)Suchan Kim (1)
FEI number 3004723334 · most recent document May 21, 2025
About Acino Products, LLC
How many FDA Form 483s has Acino Products, LLC received?
FDA Intel has 2 Form 483s on file for Acino Products, LLC; the most recent is dated May 21, 2025.
When was Acino Products, LLC last inspected by FDA?
The most recent FDA inspection document on file for Acino Products, LLC is a Form 483 dated May 21, 2025, for the site in Hamilton, New Jersey.
What did FDA cite at Acino Products, LLC?
The regulations cited most in the observations on file for Acino Products, LLC are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.