C. B. Fleet Co
Form 483 issued December 1, 2023 · Lynchburg, Virginia
- Inspection
- Nov 27 – Dec 1, 2023
- Observations
- 3
- Pages
- 4
- FEI number
- 1111503
In short: On December 1, 2023, FDA issued a Form 483 with 3 observations to C. B. Fleet Co in Lynchburg, Virginia (FEI 1111503) after an inspection that ran Nov 27 – Dec 1, 2023. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
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
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Questions about this 483
What did FDA find at C. B. Fleet Co?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was C. B. Fleet Co inspected by FDA?
The inspection ran Nov 27 – Dec 1, 2023, and the Form 483 is dated December 1, 2023.
How do I get the full Form 483 for C. B. Fleet Co?
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.