Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-14.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Feb 2025 – 14 Feb 2025 | Human Drugs | 483 | View 483 → |
| 18 Feb 2019 – 22 Feb 2019 | Human Drugs | 483 | On file |
| 25 Apr 2016 – 29 Apr 2016 | Human Drugs | 483 | On file |
| 29 Jun 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Feb 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Felix Maldonado
22 Feb 2019
21 CFR 211.52
Washing and toilet facilities not provided and accessible
Cited by Felix Maldonado
Investigators
FDA investigators tied to this site in the record.
Arsen Karapetyan1 insp.
Felix Maldonado1 insp.
Tomika L Bivens1 insp.
Freddy Ortiz Colon1 insp.
Virgilio F Pacio1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Softgel Healthcare Private Limited'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