Eugia SEZ Private Limited
Form 483 issued February 29, 2024 · Mahabubnagar District, India
- Inspection
- Feb 29, 2024
- Investigators
- Ashar P. Parikh· Marcellinus D. Dordunoo
- Observations
- 7
- Pages
- 9
- FEI number
- 3011905047
In short: On February 29, 2024, FDA issued a Form 483 with 7 observations to Eugia SEZ Private Limited in Mahabubnagar District, India (FEI 3011905047) after an inspection that ran Feb 29, 2024. The investigators were Ashar P. Parikh and Marcellinus D. Dordunoo. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production 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
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Written records are not always made of…
- 03
Equipment used in the manufacture, processing, packing or holding of diug products is not suitably located…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Ashar P. Parikh
19 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmEugia SEZ Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia SEZ Private Limited?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Eugia SEZ Private Limited?
Ashar P. Parikh and Marcellinus D. Dordunoo are named on this Form 483, for the inspection of Feb 29, 2024. Each investigator has a profile showing what they cite most.
When was Eugia SEZ Private Limited inspected by FDA?
The inspection ran Feb 29, 2024, and the Form 483 is dated February 29, 2024.
How do I get the full Form 483 for Eugia SEZ 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.