Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-08-22.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Aug 2018 – 22 Aug 2018 | Human Drugs | 483 | View 483 → |
| 9 Mar 2018 – 22 Mar 2018 | Human Drugs | 483 | View 483 → |
| 12 Jun 2017 – 29 Jun 2017 | Human Drugs | 483 | View 483 → |
| 14 Sep 2016 – 14 Oct 2016 | Human Drugs | 483 | View 483 → |
| 15 Oct 2013 – 4 Nov 2013 | Human Drugs | WL | View 483 → |
| 21 Oct 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Aug 2018
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Bonita S Chester, Claire M Minden
22 Aug 2018
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Bonita S Chester, Claire M Minden
22 Aug 2018
21 CFR 211.68(b)
Computer control of master formula records
Cited by Bonita S Chester, Claire M Minden
22 Mar 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Scott T Ballard, Camerson E Moore, Sara Rothman
22 Mar 2018
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Scott T Ballard, Camerson E Moore, Sara Rothman
Investigators
FDA investigators tied to this site in the record.
Latorie S Jones2 insp.
Torrance J Slayton2 insp.
Bonita S Chester1 insp.
Claire M Minden1 insp.
Scott T Ballard1 insp.
Camerson E Moore1 insp.
Sara Rothman1 insp.
Massoud Motamed1 insp.
Haijing Hu1 insp.
Lisa R Whitt1 insp.
Shelby N Marler1 insp.
Lisa R Jennings1 insp.
Elizabeth D Connell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cantrell Drug Company's 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat