Aurobindo Pharma, Ltd. Unit 01
Form 483 issued August 12, 2021 · Sangareddy, India
- Inspection
- Aug 2 – Aug 12, 2021
- Investigator
- Rita K. Kabaso
- Observations
- 7
- Pages
- 6
- FEI number
- 3004021253
In short: On August 12, 2021, FDA issued a Form 483 with 7 observations to Aurobindo Pharma, Ltd. Unit 01 in Sangareddy, Telangana (FEI 3004021253) after an inspection that ran Aug 2 – Aug 12, 2021. The investigator was Rita K. Kabaso. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
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
Systems for evaluating and qualifying critical…
- 02
Inadequate sampling plans for…
- 03
Components used in manufacturing are not tested and…
- 04
Proposed changes are not…
This inspection in context
Rita K. Kabaso
18 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAurobindo Pharma, Ltd. Unit 01 history
All 5 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. Unit 01?
FDA listed 7 observations on this Form 483, mostly about production, materials and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma, Ltd. Unit 01?
Rita K. Kabaso is named on this Form 483, for the inspection of Aug 2 – Aug 12, 2021. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma, Ltd. Unit 01 inspected by FDA?
The inspection ran Aug 2 – Aug 12, 2021, and the Form 483 is dated August 12, 2021.
How do I get the full Form 483 for Aurobindo Pharma, Ltd. Unit 01?
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.