Acino Products, LLC
Form 483 issued May 21, 2025 · Hamilton, New Jersey
- Inspection
- May 14 – May 21, 2025
- Investigators
- James R. Birkenstamm· Suchan Kim
- Observations
- 3
- Pages
- 4
- FEI number
- 3004723334
In short: On May 21, 2025, FDA issued a Form 483 with 3 observations to Acino Products, LLC in Hamilton, New Jersey (FEI 3004723334) after an inspection that ran May 14 – May 21, 2025. The investigators were James R. Birkenstamm and Suchan Kim. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture…
- 02
An adequate number of batches of each drug product are not tested nor are records of…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
James R. Birkenstamm
12 documents · 2018–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmAcino Products, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.46(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Acino Products, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Acino Products, LLC?
James R. Birkenstamm and Suchan Kim are named on this Form 483, for the inspection of May 14 – May 21, 2025. Each investigator has a profile showing what they cite most.
When was Acino Products, LLC inspected by FDA?
The inspection ran May 14 – May 21, 2025, and the Form 483 is dated May 21, 2025.
How do I get the full Form 483 for Acino Products, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.