Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-10-09.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Sep 2019 – 9 Oct 2019 | Foods & Cosmetics | Clean | |
| 26 Sep 2016 – 13 Oct 2016 | Foods & Cosmetics | Clean | |
| 26 Jan 2015 – 10 Feb 2015 | Foods & Cosmetics | 483 | View 483 → |
| 26 Aug 2013 – 10 Sep 2013 | Foods & Cosmetics | 483 | View 483 → |
| 2 Jul 2012 | Not recorded | 483 | View 483 → |
| 2 Oct 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2015
21 CFR 111.55
Production, process controls - implement
Cited by Peter T Erlandson, Katherine A Clarke Girolamo
10 Feb 2015
21 CFR 111.70(c)(2)
Specifications identity, purity strength, composition
Cited by Peter T Erlandson, Katherine A Clarke Girolamo
10 Feb 2015
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Peter T Erlandson, Katherine A Clarke Girolamo
10 Feb 2015
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Peter T Erlandson, Katherine A Clarke Girolamo
10 Sep 2013
21 CFR 111.27(a)
Equipment - design - suitable
Cited by Joel D Hustedt, Kimberly W Destromp
Investigators
FDA investigators tied to this site in the record.
Joel D Hustedt3 insp.
Katherine A Clarke Girolamo2 insp.
Sarah A Palmer1 insp.
Alecia L Marson1 insp.
Jennifer Guttuso1 insp.
Peter T Erlandson1 insp.
Kimberly W Destromp1 insp.
Catherine M Hollman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.15(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.355 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.605(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Standard Process, Inc.'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