Carolina Biological Supply Co
Form 483 issued September 23, 2022 · Burlington, North Carolina
- Inspection
- Sep 19 – Sep 23, 2022
- Investigators
- Christopher B. May· Nikki S. Bryant
- Observations
- 6
- Pages
- 6
- FEI number
- 1000111286
In short: On September 23, 2022, FDA issued a Form 483 with 6 observations to Carolina Biological Supply Co in Burlington, North Carolina (FEI 1000111286) after an inspection that ran Sep 19 – Sep 23, 2022. The investigators were Christopher B. May and Nikki S. Bryant. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Written MDR procedures have…
- 03
Documents were not approved by designated individual(s)…
- 04
Process control procediues that describe any process controls necessary to ensure conformance to specifications have…
This inspection in context
Christopher B. May
4 documents · 2022–2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in North Carolina.
The firmCarolina Biological Supply Co history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Carolina Biological Supply Co?
FDA listed 6 observations on this Form 483, mostly about cAPA, management controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Carolina Biological Supply Co?
Christopher B. May and Nikki S. Bryant are named on this Form 483, for the inspection of Sep 19 – Sep 23, 2022. Each investigator has a profile showing what they cite most.
When was Carolina Biological Supply Co inspected by FDA?
The inspection ran Sep 19 – Sep 23, 2022, and the Form 483 is dated September 23, 2022.
How do I get the full Form 483 for Carolina Biological Supply 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.