Aurobindo Pharma Limited, Unit XI
Form 483 issued August 2, 2022 · Pydibhimavaram, India
- Inspection
- Jul 25 – Aug 2, 2022
- Investigators
- Guerlain Ulysse· Jeffrey P. Raimondi
- Observations
- 3
- Pages
- 3
- FEI number
- 3004611
In short: On August 2, 2022, FDA issued a Form 483 with 3 observations to Aurobindo Pharma Limited, Unit XI in Pydibhimavaram, Andhra Pradesh (FEI 3004611) after an inspection that ran Jul 25 – Aug 2, 2022. The investigators were Guerlain Ulysse and Jeffrey P. Raimondi. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for the clean ing and maintenance of equipment are deficient regarding the removal or obliteration…
- 02
There is a failure to thorough ly investigate any unexplained discre pancy whether or not the…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
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 XI history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurobindo Pharma Limited, Unit XI?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. 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, Unit XI?
Guerlain Ulysse and Jeffrey P. Raimondi are named on this Form 483, for the inspection of Jul 25 – Aug 2, 2022. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Limited, Unit XI inspected by FDA?
The inspection ran Jul 25 – Aug 2, 2022, and the Form 483 is dated August 2, 2022.
How do I get the full Form 483 for Aurobindo Pharma Limited, Unit XI?
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