Barr Laboratories LLC
Form 483 issued February 28, 2018 · Forest, Virginia
- Inspection
- Feb 21 – Feb 28, 2018
- Investigators
- Fabian Chaparro· Simone E. Pitts
- Observations
- 1
- Pages
- 2
- FEI number
- 3000718267
In short: On February 28, 2018, FDA issued a Form 483 with 1 observation to Barr Laboratories LLC in Forest, Virginia (FEI 3000718267) after an inspection that ran Feb 21 – Feb 28, 2018. The investigators were Fabian Chaparro and Simone E. Pitts. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written procedures for production and process controls designed to assure that the drug products have…
This inspection in context
Fabian Chaparro
1 document · 2018
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Virginia.
The firmBarr Laboratories LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Barr Laboratories LLC?
FDA listed 1 observation on this Form 483, mostly about production. 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 Barr Laboratories LLC?
Fabian Chaparro and Simone E. Pitts are named on this Form 483, for the inspection of Feb 21 – Feb 28, 2018. Each investigator has a profile showing what they cite most.
When was Barr Laboratories LLC inspected by FDA?
The inspection ran Feb 21 – Feb 28, 2018, and the Form 483 is dated February 28, 2018.
How do I get the full Form 483 for Barr Laboratories LLC?
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.