Eugia Steriles Private Limited
Form 483 issued April 5, 2024 · Anakapalli, India
- Inspection
- Mar 28 – Apr 5, 2024
- Investigator
- Teresa I. Navas
- Observations
- 3
- Pages
- 5
- FEI number
- 3027357163
In short: On April 5, 2024, FDA issued a Form 483 with 3 observations to Eugia Steriles Private Limited in Anakapalli, Andhra Pradesh (FEI 3027357163) after an inspection that ran Mar 28 – Apr 5, 2024. The investigator was Teresa I. Navas. Most observations concern production and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern production.
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 sterile are…
- 02
Input to and output from the computer and records or data are…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmEugia Steriles 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia Steriles Private Limited?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Eugia Steriles Private Limited?
Teresa I. Navas is named on this Form 483, for the inspection of Mar 28 – Apr 5, 2024. Each investigator has a profile showing what they cite most.
When was Eugia Steriles Private Limited inspected by FDA?
The inspection ran Mar 28 – Apr 5, 2024, and the Form 483 is dated April 5, 2024.
How do I get the full Form 483 for Eugia Steriles 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.