Amneal Pharmaceuticals Private Limited
Form 483 issued May 2, 2023 · Ahmedabad, India
- Inspection
- Apr 24 – May 2, 2023
- Investigator
- Jose Velez
- Observations
- 2
- Pages
- 3
- FEI number
- 3017573557
In short: On May 2, 2023, FDA issued a Form 483 with 2 observations to Amneal Pharmaceuticals Private Limited in Ahmedabad, Gujarat (FEI 3017573557) after an inspection that ran Apr 24 – May 2, 2023. The investigator was Jose Velez. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.160 (1×)
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
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmAmneal Pharmaceuticals Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amneal Pharmaceuticals Private Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals Private Limited?
Jose Velez is named on this Form 483, for the inspection of Apr 24 – May 2, 2023. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Apr 24 – May 2, 2023, and the Form 483 is dated May 2, 2023.
How do I get the full Form 483 for Amneal Pharmaceuticals Private Limited?
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.