Acino Products, LLC
Form 483 issued June 12, 2019 · Hamilton, New Jersey
- Inspection
- May 28 – Jun 12, 2019
- Investigator
- Russell J. Glapion
- Observations
- 7
- Pages
- 5
- FEI number
- 3004723334
In short: On June 12, 2019, FDA issued a Form 483 with 7 observations to Acino Products, LLC in Hamilton, New Jersey (FEI 3004723334) after an inspection that ran May 28 – Jun 12, 2019. The investigator was Russell J. Glapion. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
Cites 211.42 (design and construction features) 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Acino Products, LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Acino Products, LLC?
Russell J. Glapion is named on this Form 483, for the inspection of May 28 – Jun 12, 2019. Each investigator has a profile showing what they cite most.
When was Acino Products, LLC inspected by FDA?
The inspection ran May 28 – Jun 12, 2019, and the Form 483 is dated June 12, 2019.
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.