C. B. Fleet Co
Form 483 issued March 12, 2015 · Lynchburg, Virginia
- Inspection
- Mar 3 – Mar 12, 2015
- Investigators
- James Michael Simpson· Jonathan W. Chapman
- Observations
- 2
- Pages
- 2
- FEI number
- 1111503
In short: On March 12, 2015, FDA issued a Form 483 with 2 observations to C. B. Fleet Co in Lynchburg, Virginia (FEI 1111503) after an inspection that ran Mar 3 – Mar 12, 2015. The investigators were James Michael Simpson and Jonathan W. Chapman. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25(a) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Employees engaged in the processing and packing of a drug product lack the training required to…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
James Michael Simpson
7 documents · 2015–2018
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Virginia.
The firmC. B. Fleet Co history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C. B. Fleet Co?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected C. B. Fleet Co?
James Michael Simpson and Jonathan W. Chapman are named on this Form 483, for the inspection of Mar 3 – Mar 12, 2015. Each investigator has a profile showing what they cite most.
When was C. B. Fleet Co inspected by FDA?
The inspection ran Mar 3 – Mar 12, 2015, and the Form 483 is dated March 12, 2015.
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.