Fareva Richmond, Inc.
Form 483 issued September 18, 2023 · Henrico, Virginia
- Inspection
- Sep 6 – Sep 18, 2023
- Investigator
- Karen A. Briggs
- Observations
- 7
- Pages
- 7
- FEI number
- 1120199
In short: On September 18, 2023, FDA issued a Form 483 with 7 observations to Fareva Richmond, Inc. in Henrico, Virginia (FEI 1120199) after an inspection that ran Sep 6 – Sep 18, 2023. The investigator was Karen A. Briggs. Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
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
Inspection of the packaging and labeling facilities is not done after use to assure that materials…
- 03
There was a failure to handle and store drug product containers at all times in a…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Karen A. Briggs
19 documents · 2021–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.
The firmFareva Richmond, Inc. 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 Fareva Richmond, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, packaging & labeling and materials. The opening words of each observation are shown on this page.
Who inspected Fareva Richmond, Inc.?
Karen A. Briggs is named on this Form 483, for the inspection of Sep 6 – Sep 18, 2023. Each investigator has a profile showing what they cite most.
When was Fareva Richmond, Inc. inspected by FDA?
The inspection ran Sep 6 – Sep 18, 2023, and the Form 483 is dated September 18, 2023.
How do I get the full Form 483 for Fareva Richmond, Inc.?
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.