Norbrook Laboratories Limited
Form 483 issued October 15, 2021 · Newry, United Kingdom
- Inspection
- Oct 4 – Oct 15, 2021
- Investigator
- Jennifer L. Huntington
- Observations
- 2
- Pages
- 4
- FEI number
- 3005587188
In short: On October 15, 2021, FDA issued a Form 483 with 2 observations to Norbrook Laboratories Limited in Newry, County Down (FEI 3005587188) after an inspection that ran Oct 4 – Oct 15, 2021. The investigator was Jennifer L. Huntington. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Norbrook Laboratories Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Norbrook Laboratories Limited?
Jennifer L. Huntington is named on this Form 483, for the inspection of Oct 4 – Oct 15, 2021. Each investigator has a profile showing what they cite most.
When was Norbrook Laboratories Limited inspected by FDA?
The inspection ran Oct 4 – Oct 15, 2021, and the Form 483 is dated October 15, 2021.
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.