Centaur Pharmaceuticals Private Limited
Form 483 issued February 8, 2023 · Pune, India
- Inspection
- Jan 30 – Feb 8, 2023
- Investigator
- Pratik S. Upadhyay
- Observations
- 4
- Pages
- 10
- FEI number
- 3008861619
In short: On February 8, 2023, FDA issued a Form 483 with 4 observations to Centaur Pharmaceuticals Private Limited in Pune, Maharashtra (FEI 3008861619) after an inspection that ran Jan 30 – Feb 8, 2023. The investigator was Pratik S. Upadhyay. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 4 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
Established test procedures and laboratory control…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCentaur Pharmaceuticals Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Centaur Pharmaceuticals Private Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Centaur Pharmaceuticals Private Limited?
Pratik S. Upadhyay is named on this Form 483, for the inspection of Jan 30 – Feb 8, 2023. Each investigator has a profile showing what they cite most.
When was Centaur Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Jan 30 – Feb 8, 2023, and the Form 483 is dated February 8, 2023.
How do I get the full Form 483 for Centaur Pharmaceuticals Private Limited?
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.