FDA-Inspected Site

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

2 FDA inspections are on record for CIRON DRUGS AND PHARMACEUTICALS PVT LTD in Tarapur, India.

483· Form 483 issued

Tarapur, 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 2023-04-25.

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
17 Apr 2023 – 25 Apr 2023Human Drugs483On file
12 Sep 2022 – 21 Sep 2022Human Drugs483On file

Observations on record

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

25 Apr 2023
21 CFR 211.110(c)

In-process materials characteristics testing

Cited by Bijoy Panicker

25 Apr 2023
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Bijoy Panicker

21 Sep 2022
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Michael A Charles

21 Sep 2022
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Michael A Charles

21 Sep 2022
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Michael A Charles

Investigators

FDA investigators tied to this site in the record.

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 211.110(c)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind CIRON DRUGS AND PHARMACEUTICALS PVT LTD'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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