CIRON DRUGS AND PHARMACEUTICALS PVT LTD
Form 483 issued September 21, 2022 · Tarapur, India
- Inspection
- Sep 12 – Sep 21, 2022
- Investigator
- Michael A. Charles
- Observations
- 4
- Pages
- 5
- FEI number
- 3017545500
In short: On September 21, 2022, FDA issued a Form 483 with 4 observations to CIRON DRUGS AND PHARMACEUTICALS PVT LTD in Tarapur, Maharashtra (FEI 3017545500) after an inspection that ran Sep 12 – Sep 21, 2022. The investigator was Michael A. Charles. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmCIRON DRUGS AND PHARMACEUTICALS PVT LTD history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CIRON DRUGS AND PHARMACEUTICALS PVT LTD?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
Who inspected CIRON DRUGS AND PHARMACEUTICALS PVT LTD?
Michael A. Charles is named on this Form 483, for the inspection of Sep 12 – Sep 21, 2022. Each investigator has a profile showing what they cite most.
When was CIRON DRUGS AND PHARMACEUTICALS PVT LTD inspected by FDA?
The inspection ran Sep 12 – Sep 21, 2022, and the Form 483 is dated September 21, 2022.
How do I get the full Form 483 for CIRON DRUGS AND PHARMACEUTICALS PVT 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.