Aurobindo Pharma Limited
Form 483 issued May 24, 2019 · Medchal, India
- Inspection
- May 13 – May 24, 2019
- Investigator
- Arsen Karapetyan
- Observations
- 1
- Pages
- 15
- FEI number
- 3004021229
In short: On May 24, 2019, FDA issued a Form 483 with 1 observation to Aurobindo Pharma Limited in Medchal, India (FEI 3004021229) after an inspection that ran May 13 – May 24, 2019. The investigator was Arsen Karapetyan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurobindo Pharma Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. 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 Aurobindo Pharma Limited?
Arsen Karapetyan is named on this Form 483, for the inspection of May 13 – May 24, 2019. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Limited inspected by FDA?
The inspection ran May 13 – May 24, 2019, and the Form 483 is dated May 24, 2019.
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.