Amneal Pharmaceuticals Private Limited
Form 483 issued March 19, 2025 · Mehsana, India
- Inspection
- Mar 10 – Mar 19, 2025
- Investigators
- Alan A. Rivera· Anastasia M. Shields
- Observations
- 4
- Pages
- 5
- FEI number
- 3018907202
In short: On March 19, 2025, FDA issued a Form 483 with 4 observations to Amneal Pharmaceuticals Private Limited in Mehsana, Gujarat (FEI 3018907202) after an inspection that ran Mar 10 – Mar 19, 2025. The investigators were Alan A. Rivera and Anastasia M. Shields. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
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 any unexplained discrepancy and the failure of a batch…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate designed to assure that…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmAmneal Pharmaceuticals Private Limited 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 Pharmaceuticals Private Limited?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals Private Limited?
Alan A. Rivera and Anastasia M. Shields are named on this Form 483, for the inspection of Mar 10 – Mar 19, 2025. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Mar 10 – Mar 19, 2025, and the Form 483 is dated March 19, 2025.
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.