Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-03-06.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Mar 2020 – 6 Mar 2020 | Human Drugs | WL | View 483 → |
| 4 Dec 2017 – 8 Dec 2017 | Human Drugs | 483 | View 483 → |
| 23 Mar 2015 – 27 Mar 2015 | Human Drugs | 483 | On file |
| 15 Dec 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Mar 2020
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Nicholas A Violand
Investigators
FDA investigators tied to this site in the record.
Nicholas A Violand1 insp.
Taichun Qin1 insp.
Gam S Zamil1 insp.
Edward D Mcdonald1 insp.
Yumi J Hiramine1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | 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 Willard Manufacturing Inc.'s 4 Form 483s
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