Aurobindo Pharma Limited (Unit 1)
Form 483 issued August 12, 2021 · Doultabad, India
- Inspection
- Aug 2 – Aug 12, 2021
- Investigator
- Rita K. Kabaso
- Observations
- 7
- Pages
- 6
In short: On August 12, 2021, FDA issued a Form 483 with 7 observations to Aurobindo Pharma Limited (Unit 1) in Doultabad, India after an inspection that ran Aug 2 – Aug 12, 2021. The investigator was Rita K. Kabaso. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
2 of 3 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (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 qualilying critical…
- 02
Inadequate sampling plans for…
- 03
Components used in manufacturing are not test and…
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 Limited (Unit 1) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurobindo Pharma Limited (Unit 1)?
FDA listed 7 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma Limited (Unit 1)?
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 Limited (Unit 1) 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 Limited (Unit 1)?
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