Aurobindo Pharma Limited
Form 483 issued July 21, 2023 · Medchal, India
- Inspection
- Jul 14 – Jul 21, 2023
- Investigators
- Anastasia M. Shields· Andrew Le
- Observations
- 3
- Pages
- 2
- FEI number
- 3004021229
In short: On July 21, 2023, FDA issued a Form 483 with 3 observations to Aurobindo Pharma Limited in Medchal, Telangana (FEI 3004021229) after an inspection that ran Jul 14 – Jul 21, 2023. The investigators were Anastasia M. Shields and Andrew Le. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained. in…
- 03
Established laboratory control mechanisms…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmAurobindo Pharma Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurobindo Pharma Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma Limited?
Anastasia M. Shields and Andrew Le are named on this Form 483, for the inspection of Jul 14 – Jul 21, 2023. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Limited inspected by FDA?
The inspection ran Jul 14 – Jul 21, 2023, and the Form 483 is dated July 21, 2023.
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.