Norbrook Laboratories, Ltd
Form 483 issued February 7, 2020 · Newry
- Inspection
- Jan 20 – Feb 7, 2020
- Investigator
- Roger F. Zabinski
- Observations
- 6
- Pages
- 9
- FEI number
- 3002874838
In short: On February 7, 2020, FDA issued a Form 483 with 6 observations to Norbrook Laboratories, Ltd in Newry (FEI 3002874838) after an inspection that ran Jan 20 – Feb 7, 2020. The investigator was Roger F. Zabinski. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The written stability testing program is not followed. The stability program has not always been followed…
- 02
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
- 03
Written procedures are not drafted, reviewed and approved by the appropriate organizational units. The firm has…
- 04
Each component is not added to a batch by one person and verified by a second…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmNorbrook Laboratories, Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Norbrook Laboratories, Ltd?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Norbrook Laboratories, Ltd?
Roger F. Zabinski is named on this Form 483, for the inspection of Jan 20 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was Norbrook Laboratories, Ltd inspected by FDA?
The inspection ran Jan 20 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
How do I get the full Form 483 for Norbrook Laboratories, Ltd?
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.