Cantrell Drug Company
Form 483 issued October 14, 2016 · Little Rock, Arkansas
- Inspection
- Sep 14 – Oct 14, 2016
- Investigators
- Latorie S. Jones· Lisa R. Jennings· Shelby N. Marler
- Observations
- 12
- Pages
- 22
- FEI number
- 3004483441
In short: On October 14, 2016, FDA issued a Form 483 with 12 observations to Cantrell Drug Company in Little Rock, Arkansas (FEI 3004483441) after an inspection that ran Sep 14 – Oct 14, 2016. The investigators were Latorie S. Jones, Lisa R. Jennings and Shelby N. Marler. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning an d disinfecting the room and…
- 02
Procedures designed to prevent microbiological contamination of dmg products pmporting to be sterile are not…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 04
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
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(c)(10)(v)
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, laboratory controls 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?
Latorie S. Jones, Lisa R. Jennings and Shelby N. Marler are named on this Form 483, for the inspection of Sep 14 – Oct 14, 2016. Each investigator has a profile showing what they cite most.
When was Cantrell Drug Company inspected by FDA?
The inspection ran Sep 14 – Oct 14, 2016, and the Form 483 is dated October 14, 2016.
How do I get the full Form 483 for Cantrell Drug Company?
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