BROOKS STERISCIENCE LIMITED
Form 483 issued February 1, 2023 · Vadodara, India
- Inspection
- Jan 23 – Feb 1, 2023
- Investigator
- Jose M. Cayuela
- Observations
- 2
- Pages
- 3
- FEI number
- 3018899465
In short: On February 1, 2023, FDA issued a Form 483 with 2 observations to BROOKS STERISCIENCE LIMITED in Vadodara, Gujarat (FEI 3018899465) after an inspection that ran Jan 23 – Feb 1, 2023. The investigator was Jose M. Cayuela. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.160 (1×)
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…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmBROOKS STERISCIENCE LIMITED history
The site's inspection history, in date order.
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 BROOKS STERISCIENCE LIMITED?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected BROOKS STERISCIENCE LIMITED?
Jose M. Cayuela is named on this Form 483, for the inspection of Jan 23 – Feb 1, 2023. Each investigator has a profile showing what they cite most.
When was BROOKS STERISCIENCE LIMITED inspected by FDA?
The inspection ran Jan 23 – Feb 1, 2023, and the Form 483 is dated February 1, 2023.
How do I get the full Form 483 for BROOKS STERISCIENCE 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.