Aurobindo Pharma Limited Unit lX
Form 483 issued November 18, 2022 · Hatnoora Mandal Sangareddy, India
- Inspection
- Nov 10 – Nov 18, 2022
- Investigators
- Arsen Karapetyan· Lata Mathew
- Observations
- 1
- Pages
- 17
- FEI number
- 3006370489
In short: On November 18, 2022, FDA issued a Form 483 with 1 observation to Aurobindo Pharma Limited Unit lX in Hatnoora Mandal Sangareddy, India (FEI 3006370489) after an inspection that ran Nov 10 – Nov 18, 2022. The investigators were Arsen Karapetyan and Lata Mathew. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Out of Specification and Complaint Investigations for /\Pl…
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 Unit lX 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 Unit lX?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma Limited Unit lX?
Arsen Karapetyan and Lata Mathew are named on this Form 483, for the inspection of Nov 10 – Nov 18, 2022. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Limited Unit lX inspected by FDA?
The inspection ran Nov 10 – Nov 18, 2022, and the Form 483 is dated November 18, 2022.
How do I get the full Form 483 for Aurobindo Pharma Limited Unit lX?
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