Cantrell Drug Company
Form 483 issued August 22, 2018 · Little Rock, Arkansas
- Inspection
- Aug 14, 2020
- Investigator
- Claire M. Minden
- Observations
- 3
- Pages
- 3
- FEI number
- 3004483441
In short: On August 22, 2018, FDA issued a Form 483 with 3 observations to Cantrell Drug Company in Little Rock, Arkansas (FEI 3004483441) after an inspection that ran Aug 14, 2020. The investigator was Claire M. Minden. Most observations concern facilities & equipment.
At a glance
3 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
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 02
Equipment for adequate control over humidity is not provided when appropriate for the manufacture, processing, packing…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmCantrell Drug Company history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cantrell Drug Company?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Cantrell Drug Company?
Claire M. Minden is named on this Form 483, for the inspection of Aug 14, 2020. Each investigator has a profile showing what they cite most.
When was Cantrell Drug Company inspected by FDA?
The inspection ran Aug 14, 2020, and the Form 483 is dated August 22, 2018.
How do I get the full Form 483 for Cantrell Drug Company?
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.