Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-08-16.
At a glance
Inspections
8
Form 483s
5
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Aug 2019 – 16 Aug 2019 | Foods & Cosmetics | Clean | |
| 15 Jun 2016 | Foods & Cosmetics | 483 | View 483 → |
| 8 Mar 2012 | Not recorded | 483 | On file |
| 2 Feb 2012 | Not recorded | 483 | View 483 → |
| 8 Sep 2010 | Not recorded | 483 | View 483 → |
| 11 Jun 2009 | Not recorded | 483 | On file |
| 19 Mar 2009 | Not recorded | Clean | |
| 8 Sep 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jun 2016
21 CFR 120.8(b)(3)
HACCP plan - critical limits not listed or not adequate
Cited by Kevin T Gerrity, Kendra J Vieira
15 Jun 2016
21 CFR 120.8(a)
HACCP plan - location and type of juice
Cited by Kevin T Gerrity, Kendra J Vieira
2 Feb 2012
21 CFR 110.40(a)
Precluding contaminants
Cited by Jeff M Uriarte, Comyar Shoghi, Carla J Lundi
Investigators
FDA investigators tied to this site in the record.
Jeff M Uriarte2 insp.
Kevin T Gerrity1 insp.
Kendra J Vieira1 insp.
Greg K Keshishyan1 insp.
Comyar Shoghi1 insp.
Carla J Lundi1 insp.
Lilly O Barton1 insp.
David G Whitman1 insp.
Cntrctmntr Nepsa1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 120.6(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.8(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 108.25(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 108.25(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.7(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aseptic Solutions USA, LLC's 5 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