Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-22.
At a glance
Inspections
5
Form 483s
4
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Feb 2024 – 22 Feb 2024 | Foods & Cosmetics | Clean | |
| 20 Feb 2019 – 14 Mar 2019 | Human Drugs | 483 | View 483 → |
| 21 Mar 2016 – 5 Apr 2016 | Foods & Cosmetics | 483 | View 483 → |
| 19 Mar 2014 – 28 Mar 2014 | Human Drugs | 483 | View 483 → |
| 17 Nov 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Mar 2019
21 CFR 111.105(g)
Quality control - reserve samples
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
14 Mar 2019
21 CFR 111.105(g)
Quality control - reserve samples
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
14 Mar 2019
21 CFR 111.105(g)
Quality control - reserve samples
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
14 Mar 2019
21 CFR 111.123(a)(5)
Quality control operations - reprocessing
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
14 Mar 2019
21 CFR 111.123(a)(5)
Quality control operations - reprocessing
Cited by Marinee Flores-Marrero, Lissette Paiz, Rozelle G Smith
Investigators
FDA investigators tied to this site in the record.
Lissette Paiz2 insp.
Marinee Flores-Marrero1 insp.
Rozelle G Smith1 insp.
Gina C Chen1 insp.
John J Bernal1 insp.
Karl D Hezel1 insp.
Ileana Barreto-Pettit1 insp.
Joanne E King1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 13x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 111.105(g) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.123(a)(5) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.27(a)(2) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.365(i) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.325(b)(2)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.355 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Innova SoftGel LLC's 4 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