Amneal Complex Products Research LLC
Form 483 issued April 18, 2018 · Bridgewater, New Jersey
- Inspection
- Apr 3 – Apr 18, 2018
- Investigator
- Nancy F. Scheraga
- Observations
- 2
- Pages
- 2
- FEI number
- 3010529997
In short: On April 18, 2018, FDA issued a Form 483 with 2 observations to Amneal Complex Products Research LLC in Bridgewater, New Jersey (FEI 3010529997) after an inspection that ran Apr 3 – Apr 18, 2018. The investigator was Nancy F. Scheraga. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Nancy F. Scheraga
9 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) 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 211.192
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 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Amneal Complex Products Research LLC?
Nancy F. Scheraga is named on this Form 483, for the inspection of Apr 3 – Apr 18, 2018. Each investigator has a profile showing what they cite most.
When was Amneal Complex Products Research LLC inspected by FDA?
The inspection ran Apr 3 – Apr 18, 2018, and the Form 483 is dated April 18, 2018.
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.