Aurobindo Pharma Ltd.
Form 483 issued September 5, 2025 · Bachupallv, India
- Inspection
- Aug 25 – Sep 5, 2025
- Investigators
- Claudia M. Perez-Kasmarski· Eileen A. Liu· Joseph A. Piechocki
- Observations
- 8
- Pages
- 15
- FEI number
- 3004446312
In short: On September 5, 2025, FDA issued a Form 483 with 8 observations to Aurobindo Pharma Ltd. in Bachupallv, India (FEI 3004446312) after an inspection that ran Aug 25 – Sep 5, 2025. The investigators were Claudia M. Perez-Kasmarski, Eileen A. Liu and Joseph A. Piechocki. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.100 (2×)
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 microbiological contamination of drug products purporting to be sterile are not established…
- 02
Aseptic processing area are deficient regarding the system…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Claudia M. Perez-Kasmarski
11 documents · 2020–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmAurobindo Pharma Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurobindo Pharma Ltd.?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and 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 Aurobindo Pharma Ltd.?
Claudia M. Perez-Kasmarski, Eileen A. Liu and Joseph A. Piechocki are named on this Form 483, for the inspection of Aug 25 – Sep 5, 2025. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Ltd. inspected by FDA?
The inspection ran Aug 25 – Sep 5, 2025, and the Form 483 is dated September 5, 2025.
How do I get the full Form 483 for Aurobindo Pharma Ltd.?
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.