Eugia Steriles Private Limited
Form 483 issued February 18, 2025 · Anakapalli, India
- Inspection
- Feb 10 – Feb 18, 2025
- Investigator
- Ashar P. Parikh
- Observations
- 5
- Pages
- 5
- FEI number
- 3027357163
In short: On February 18, 2025, FDA issued a Form 483 with 5 observations to Eugia Steriles Private Limited in Anakapalli, Andhra Pradesh (FEI 3027357163) after an inspection that ran Feb 10 – Feb 18, 2025. The investigator was Ashar P. Parikh. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Written procedures for sampling and testing plans are not followed…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
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 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia Steriles Private Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Eugia Steriles Private Limited?
Ashar P. Parikh is named on this Form 483, for the inspection of Feb 10 – Feb 18, 2025. Each investigator has a profile showing what they cite most.
When was Eugia Steriles Private Limited inspected by FDA?
The inspection ran Feb 10 – Feb 18, 2025, and the Form 483 is dated February 18, 2025.
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.