Aurobindo Pharma Limited
Form 483 issued May 10, 2022 · Polepally, Mahaboob Nagar, India
- Inspection
- May 2 – May 10, 2022
- Investigators
- Darren S. Brown· Justin A. Boyd
- Observations
- 6
- Pages
- 13
- FEI number
- 3007373532
In short: On May 10, 2022, FDA issued a Form 483 with 6 observations to Aurobindo Pharma Limited in Polepally, Mahaboob Nagar, India (FEI 3007373532) after an inspection that ran May 2 – May 10, 2022. The investigators were Darren S. Brown and Justin A. Boyd. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmAurobindo Pharma 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 Aurobindo Pharma Limited?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma Limited?
Darren S. Brown and Justin A. Boyd are named on this Form 483, for the inspection of May 2 – May 10, 2022. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Limited inspected by FDA?
The inspection ran May 2 – May 10, 2022, and the Form 483 is dated May 10, 2022.
How do I get the full Form 483 for Aurobindo Pharma 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.