AURORE PHARMACEUTICALS PRIVATE LIMITED
Form 483 issued May 31, 2024 · Hyderabad, India
- Inspection
- May 27 – May 31, 2024
- Investigator
- Teresa I. Navas
- Observations
- 5
- Pages
- 4
- FEI number
- 3003937580
In short: On May 31, 2024, FDA issued a Form 483 with 5 observations to AURORE PHARMACEUTICALS PRIVATE LIMITED in Hyderabad, Telangana (FEI 3003937580) after an inspection that ran May 27 – May 31, 2024. The investigator was Teresa I. Navas. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to clean and maintain equipment to prevent contamination or carry-over of a material that would…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
There is a failure to thoroughly review failures whether or not the batch…
- 04
Buildings used in the manufacture of APIs…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAURORE PHARMACEUTICALS PRIVATE LIMITED 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 AURORE PHARMACEUTICALS PRIVATE LIMITED?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected AURORE PHARMACEUTICALS PRIVATE LIMITED?
Teresa I. Navas is named on this Form 483, for the inspection of May 27 – May 31, 2024. Each investigator has a profile showing what they cite most.
When was AURORE PHARMACEUTICALS PRIVATE LIMITED inspected by FDA?
The inspection ran May 27 – May 31, 2024, and the Form 483 is dated May 31, 2024.
How do I get the full Form 483 for AURORE PHARMACEUTICALS PRIVATE LIMITED?
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