Norbrook Laboratories Limited
Form 483 issued March 29, 2024 · Newry, United Kingdom
- Inspection
- Mar 18 – Mar 29, 2024
- Investigator
- Khoa Nathan V. Tran
- Observations
- 3
- Pages
- 9
- FEI number
- 3005587188
In short: On March 29, 2024, FDA issued a Form 483 with 3 observations to Norbrook Laboratories Limited in Newry, County Down (FEI 3005587188) after an inspection that ran Mar 18 – Mar 29, 2024. The investigator was Khoa Nathan V. Tran. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
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 sterile are…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmNorbrook Laboratories 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Norbrook Laboratories Limited?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Norbrook Laboratories Limited?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Mar 18 – Mar 29, 2024. Each investigator has a profile showing what they cite most.
When was Norbrook Laboratories Limited inspected by FDA?
The inspection ran Mar 18 – Mar 29, 2024, and the Form 483 is dated March 29, 2024.
How do I get the full Form 483 for Norbrook Laboratories 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.