FDA-Inspected Site

Eugia Steriles Private Limited

2 FDA inspections are on record for Eugia Steriles Private Limited in Anakapalli, India.

483· Form 483 issued

Anakapalli, India · Last updated July 11, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-02-18.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Feb 2025 – 18 Feb 2025Human Drugs483View 483 →
28 Mar 2024 – 5 Apr 2024Human Drugs483On file

Observations on record

Form 483 observations cited at this site, most recent first.

18 Feb 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Ashar P Parikh

18 Feb 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Ashar P Parikh

18 Feb 2025
21 CFR 211.165(c)

Sampling and testing plans not followed

Cited by Ashar P Parikh

18 Feb 2025
21 CFR 211.192

Written record of investigation incomplete

Cited by Ashar P Parikh

18 Feb 2025
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Ashar P Parikh

Investigators

FDA investigators tied to this site in the record.

Teresa I Navas1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Eugia Steriles Private Limited's 2 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat

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