Cantrell Drug Company
Form 483 issued June 29, 2017 · Little Rock, Arkansas
- Inspection
- Jun 12 – Jun 29, 2017
- Investigators
- Haijing Hu· Latorie S. Jones· Massoud Motamed
- Observations
- 8
- Pages
- 14
- FEI number
- 3004483441
In short: On June 29, 2017, FDA issued a Form 483 with 8 observations to Cantrell Drug Company in Little Rock, Arkansas (FEI 3004483441) after an inspection that ran Jun 12 – Jun 29, 2017. The investigators were Haijing Hu, Latorie S. Jones and Massoud Motamed. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to fully investigate…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency paiiiculate air…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Haijing Hu
2 documents · 2016–2017
Cites 211.113 (control of microbiological contamination) 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 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cantrell Drug Company?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Cantrell Drug Company?
Haijing Hu, Latorie S. Jones and Massoud Motamed are named on this Form 483, for the inspection of Jun 12 – Jun 29, 2017. Each investigator has a profile showing what they cite most.
When was Cantrell Drug Company inspected by FDA?
The inspection ran Jun 12 – Jun 29, 2017, and the Form 483 is dated June 29, 2017.
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.