Centaur Pharmaceuticals Private Limited
Form 483 issued January 13, 2023 · Tuem, India
- Inspection
- Jan 9 – Jan 13, 2023
- Investigator
- Sandra A. Boyd
- Observations
- 7
- Pages
- 3
- FEI number
- 3013630102
In short: On January 13, 2023, FDA issued a Form 483 with 7 observations to Centaur Pharmaceuticals Private Limited in Tuem, Goa (FEI 3013630102) after an inspection that ran Jan 9 – Jan 13, 2023. The investigator was Sandra A. Boyd. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
- 02
The written stability program for drug products does not include reliable, meaningful…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 04
Your in-process specifications for sampling and testing of in-process materials and drug products were not determined…
This inspection in context
Sandra A. Boyd
16 documents · 2019–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmCentaur Pharmaceuticals Private Limited history
The site's inspection history, in date order.
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 7 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Centaur Pharmaceuticals Private Limited?
Sandra A. Boyd is named on this Form 483, for the inspection of Jan 9 – Jan 13, 2023. Each investigator has a profile showing what they cite most.
When was Centaur Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Jan 9 – Jan 13, 2023, and the Form 483 is dated January 13, 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.