Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-09-02.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Aug 2022 – 2 Sep 2022 | Foods & Cosmetics | 483 | View 483 → |
| 7 May 2018 – 9 May 2018 | Foods & Cosmetics | 483 | View 483 → |
| 24 Feb 2017 – 6 Mar 2017 | Foods & Cosmetics | WL | View 483 → |
| 19 Mar 2014 – 21 Mar 2014 | Foods & Cosmetics | 483 | View 483 → |
| 15 Nov 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Sep 2022
21 CFR 111.110(c)
Quality control operations - tests, examinations; results
Cited by Jessica I Newman
2 Sep 2022
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Jessica I Newman
2 Sep 2022
21 CFR 111.123(a)(1)
QC operations - master manufacturing record, modifications
Cited by Jessica I Newman
Investigators
FDA investigators tied to this site in the record.
Jessica I Newman1 insp.
Courtney R Ingalsbe1 insp.
Jennifer A Robinson1 insp.
Carolyn J Cook1 insp.
Kathleen S Tormey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.610(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.375(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Innovita, LLC's 5 Form 483s
Source PDFs, 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