Amneal Pharmaceuticals, LLC
Form 483 issued February 10, 2022 · Piscataway, New Jersey
- Inspection
- Jan 24 – Feb 10, 2022
- Investigators
- Daniel L. Zheng· Jonathan G. Matrisciano
- Observations
- 2
- Pages
- 4
- FEI number
- 3008861605
In short: On February 10, 2022, FDA issued a Form 483 with 2 observations to Amneal Pharmaceuticals, LLC in Piscataway, New Jersey (FEI 3008861605) after an inspection that ran Jan 24 – Feb 10, 2022. The investigators were Daniel L. Zheng and Jonathan G. Matrisciano. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
Equipment used in the manufacture, processing, packing or holding of ding products is not of appropriate…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAmneal Pharmaceuticals, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amneal Pharmaceuticals, LLC?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals, LLC?
Daniel L. Zheng and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Jan 24 – Feb 10, 2022. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals, LLC inspected by FDA?
The inspection ran Jan 24 – Feb 10, 2022, and the Form 483 is dated February 10, 2022.
How do I get the full Form 483 for Amneal Pharmaceuticals, 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.