FDA-Inspected Site

BROOKS STERISCIENCE LIMITED

2 FDA inspections are on record for BROOKS STERISCIENCE LIMITED in Vadodara, India.

483· Form 483 issued

Vadodara, 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 2024-11-12.

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
4 Nov 2024 – 12 Nov 2024Human Drugs483View 483 →
23 Jan 2023 – 1 Feb 2023Human Drugs483View 483 →

Observations on record

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

12 Nov 2024
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Teresa I Navas

12 Nov 2024
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Teresa I Navas

12 Nov 2024
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Teresa I Navas

12 Nov 2024
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Teresa I Navas

1 Feb 2023
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Jose M Cayuela

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 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind BROOKS STERISCIENCE 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