Barr Laboratories LLC
Form 483 issued April 14, 2017 · Forest, Virginia
- Inspection
- Apr 3 – Apr 14, 2017
- Investigators
- Jonathan W. Chapman· Marcus A. Ray
- Observations
- 4
- Pages
- 5
- FEI number
- 3000718267
In short: On April 14, 2017, FDA issued a Form 483 with 4 observations to Barr Laboratories LLC in Forest, Virginia (FEI 3000718267) after an inspection that ran Apr 3 – Apr 14, 2017. The investigators were Jonathan W. Chapman and Marcus A. Ray. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
3 of 4 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
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
Component subdividing operations are…
This inspection in context
Jonathan W. Chapman
11 documents · 2014–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
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 4 observations on this Form 483, mostly about production and materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Barr Laboratories LLC?
Jonathan W. Chapman and Marcus A. Ray are named on this Form 483, for the inspection of Apr 3 – Apr 14, 2017. Each investigator has a profile showing what they cite most.
When was Barr Laboratories LLC inspected by FDA?
The inspection ran Apr 3 – Apr 14, 2017, and the Form 483 is dated April 14, 2017.
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.