Overview
- 8 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-27.
At a glance
Inspections
8
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Feb 2026 – 27 Feb 2026 | Human Drugs | 483 | View 483 → |
| 4 Dec 2023 – 8 Dec 2023 | Human Drugs | 483 | View 483 → |
| 11 Oct 2022 – 18 Oct 2022 | Human Drugs | WL | View 483 → |
| 30 Jan 2019 – 13 Feb 2019 | Foods & Cosmetics | 483 | View 483 → |
| 7 Feb 2018 – 2 Mar 2018 | Foods & Cosmetics | 483 | View 483 → |
| 2 Jun 2016 – 6 Jul 2016 | Foods & Cosmetics | 483 | View 483 → |
| 9 Oct 2015 – 22 Oct 2015 | Human Drugs | 483 | On file |
| 3 Jun 2013 – 2 Jul 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Feb 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Ivis L Negron Torres, Jose F Velez
27 Feb 2026
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Ivis L Negron Torres, Jose F Velez
27 Feb 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Ivis L Negron Torres, Jose F Velez
27 Feb 2026
21 CFR 211.160(b)(4)
Written calibration procedures
Cited by Ivis L Negron Torres, Jose F Velez
27 Feb 2026
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Ivis L Negron Torres, Jose F Velez
Investigators
FDA investigators tied to this site in the record.
Angelica M Hernandez2 insp.
Alan A Rivera2 insp.
Jorge L Lajara2 insp.
Lizaida E Rodriguez2 insp.
Ivis L Negron Torres1 insp.
Jose F Velez1 insp.
Marian E Ramirez1 insp.
Ariel Cruz Figueroa1 insp.
Maricelys Mercado1 insp.
Nydia E Colon1 insp.
Rafael Gonzalez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | 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 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gasco Industrial Corp.'s 8 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