Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-04-28.
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 |
|---|---|---|---|
| 19 Apr 2016 – 28 Apr 2016 | Human Drugs | 483 | View 483 → |
| 30 Mar 2015 – 23 Apr 2015 | Human Drugs | 483 | View 483 → |
| 10 Jul 2013 – 2 Aug 2013 | Human Drugs | 483 | View 483 → |
| 15 Aug 2012 | Not recorded | 483 | View 483 → |
| 18 Apr 2011 | Not recorded | 483 | View 483 → |
| 29 Nov 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Apr 2016
21 CFR 211.110(a)
Control procedures fail to include the following
Cited by Marcus A Ray, Tajah L Blackburn, Chaltu N Wakijra
28 Apr 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Marcus A Ray, Tajah L Blackburn, Chaltu N Wakijra
28 Apr 2016
21 CFR 211.180(c)
Records not made readily available to FDA
Cited by Marcus A Ray, Tajah L Blackburn, Chaltu N Wakijra
28 Apr 2016
21 CFR 211.188(b)(11)
Identification of Persons Performing Significant Steps
Cited by Marcus A Ray, Tajah L Blackburn, Chaltu N Wakijra
28 Apr 2016
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Marcus A Ray, Tajah L Blackburn, Chaltu N Wakijra
Investigators
FDA investigators tied to this site in the record.
Marcus A Ray1 insp.
Tajah L Blackburn1 insp.
Chaltu N Wakijra1 insp.
James M Simpson1 insp.
Collins M Mason1 insp.
Susan J Essenmacher1 insp.
La-Tasha M Gunter1 insp.
Susan S Jaughn1 insp.
Ernest Bizjak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hawknad Manufacturing Industries, Inc.'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