Amneal Complex Products Research LLC
Form 483 issued May 17, 2024 · Bridgewater, New Jersey
- Inspection
- May 13 – May 17, 2024
- Investigators
- Miral B. Patel· Rose Jean-Mary
- Observations
- 1
- Pages
- 2
- FEI number
- 3010529997
In short: On May 17, 2024, FDA issued a Form 483 with 1 observation to Amneal Complex Products Research LLC in Bridgewater, New Jersey (FEI 3010529997) after an inspection that ran May 13 – May 17, 2024. The investigators were Miral B. Patel and Rose Jean-Mary. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Miral B. Patel
2 documents · 2023–2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmAmneal Complex Products Research LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amneal Complex Products Research LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Amneal Complex Products Research LLC?
Miral B. Patel and Rose Jean-Mary are named on this Form 483, for the inspection of May 13 – May 17, 2024. Each investigator has a profile showing what they cite most.
When was Amneal Complex Products Research LLC inspected by FDA?
The inspection ran May 13 – May 17, 2024, and the Form 483 is dated May 17, 2024.
How do I get the full Form 483 for Amneal Complex Products Research 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.