Centaur Pharmaceuticals Private Ltd.
Form 483 issued November 21, 2022 · Thane, India
- Observations
- 9
- Pages
- 15
- FEI number
- 3003973520
In short: On November 21, 2022, FDA issued a Form 483 with 9 observations to Centaur Pharmaceuticals Private Ltd. in Thane, Maharashtra (FEI 3003973520). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Quality system and laboratory controls account for 6 of 9 observations.
Most cited: 21 CFR 211.194 (3×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality unit did not ensure issuance of documents is controlled and…
- 02
Laboratory data is not documented accurately and at…
- 03
Controls to prevent unauthorized changes or loss of data have not been…
- 04
Investigation, retesting, and resampling of out of specifications results was not…
This inspection in context
Questions about this 483
What did FDA find at Centaur Pharmaceuticals Private Ltd.?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
When was Centaur Pharmaceuticals Private Ltd. inspected by FDA?
This Form 483 is dated November 21, 2022.
How do I get the full Form 483 for Centaur Pharmaceuticals Private Ltd.?
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.