FDA-Inspected Site

American Pure Whey

3 FDA inspections are on record for American Pure Whey in New Bern, United States.

483· Form 483 issued

New Bern, United States · Last updated July 10, 2026

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.

InspectionCategoryOutcomeForm 483
9 Jul 2019 – 12 Jul 2019Foods & Cosmetics483View 483 →
14 Nov 2016 – 17 Nov 2016Foods & Cosmetics483View 483 →
15 Sep 2015 – 18 Sep 2015Foods & CosmeticsWLView 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

12 Jul 2019
21 CFR 111.10(b)

Personnel - hygienic practices

Cited by Sondra L Phillips

12 Jul 2019
21 CFR 111.15(b)(1)

Physical plant - clean and sanitary

Cited by Sondra L Phillips

12 Jul 2019
21 CFR 111.15(d)(2)

Pest control measures

Cited by Sondra L Phillips

12 Jul 2019
21 CFR 111.180(b)(1)

Written procedures - product received

Cited by Sondra L Phillips

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.

Perry H Gambrell1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations4x
21 CFR 111.180(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.205(b)(2)Cited across public-safe Form 483 observations3x
21 CFR 111.255(a)Cited across public-safe Form 483 observations3x
21 CFR 111.420(c)Cited across public-safe Form 483 observations3x
21 CFR 111.455(c)Cited across public-safe Form 483 observations3x
21 CFR 111.475(b)(2)Cited across public-safe Form 483 observations3x
21 CFR 111.70(a)Cited across public-safe Form 483 observations3x
21 CFR 111.75(c)(2)Cited across public-safe Form 483 observations3x
21 CFR 111.83(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.15(d)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.205(a)Cited across public-safe Form 483 observations2x
21 CFR 111.255(b)Cited across public-safe Form 483 observations2x
21 CFR 111.353Cited across public-safe Form 483 observations2x
21 CFR 111.535(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.60(a)Cited across public-safe Form 483 observations2x
21 CFR 111.10(b)Cited across public-safe Form 483 observations1x
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.15(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.180(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.20(f)Cited across public-safe Form 483 observations1x
21 CFR 111.20(h)Cited across public-safe Form 483 observations1x
21 CFR 111.27(a)(3)(v)Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x
21 CFR 111.75(c)Cited across public-safe Form 483 observations1x

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