Cantrell Drug Company
Form 483 issued November 4, 2013 · Little Rock, Arkansas
- Inspection
- Oct 15 – Nov 4, 2013
- Investigators
- Elizabeth D. Connell· Torrance J. Slayton
- Observations
- 12
- Pages
- 8
- FEI number
- 3004483441
In short: On November 4, 2013, FDA issued a Form 483 with 12 observations to Cantrell Drug Company in Little Rock, Arkansas (FEI 3004483441) after an inspection that ran Oct 15 – Nov 4, 2013. The investigators were Elizabeth D. Connell and Torrance J. Slayton. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Elizabeth D. Connell
3 documents · 2011–2013
Cites 211.42(a) (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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cantrell Drug Company?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, materials and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Cantrell Drug Company?
Elizabeth D. Connell and Torrance J. Slayton are named on this Form 483, for the inspection of Oct 15 – Nov 4, 2013. Each investigator has a profile showing what they cite most.
When was Cantrell Drug Company inspected by FDA?
The inspection ran Oct 15 – Nov 4, 2013, and the Form 483 is dated November 4, 2013.
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.