Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-07-12.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jul 2019 – 12 Jul 2019 | Foods & Cosmetics | 483 | View 483 → |
| 14 Nov 2016 – 17 Nov 2016 | Foods & Cosmetics | 483 | View 483 → |
| 15 Sep 2015 – 18 Sep 2015 | Foods & Cosmetics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jul 2019
21 CFR 111.180(b)(2)
Records - receiving; components, packaging, labels, products
Cited by Sondra L Phillips
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.180(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.420(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.475(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.83(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.15(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.535(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.60(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(3)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind American Pure Whey's 3 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