Cantrell Drug Company
Form 483 issued March 22, 2018 · Little Rock, Arkansas
- Inspection
- Mar 9 – Mar 22, 2018
- Investigators
- Camerson E. Moore· Sara Rothman· Scott Ballard
- Observations
- 7
- Pages
- 6
- FEI number
- 3004483441
In short: On March 22, 2018, FDA issued a Form 483 with 7 observations to Cantrell Drug Company in Little Rock, Arkansas (FEI 3004483441) after an inspection that ran Mar 9 – Mar 22, 2018. The investigators were Camerson E. Moore, Sara Rothman and Scott Ballard. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy did not extend to other drug products that may have been…
- 02
Complaint procedures are deficient in that they do not include provisions that allow for the review…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Component testing is deficient in that each component is not tested for conformity with all appropriate…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cantrell Drug Company?
FDA listed 7 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected Cantrell Drug Company?
Camerson E. Moore, Sara Rothman and Scott Ballard are named on this Form 483, for the inspection of Mar 9 – Mar 22, 2018. Each investigator has a profile showing what they cite most.
When was Cantrell Drug Company inspected by FDA?
The inspection ran Mar 9 – Mar 22, 2018, and the Form 483 is dated March 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.