Overview
- 23 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
23
Form 483s
10
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 13 Feb 2026 | Human Drugs | 483 | On file |
| 29 May 2024 – 6 Jun 2024 | Human Drugs | 483 | On file |
| 11 May 2021 – 12 Jul 2021 | Human Drugs | 483 | View 483 → |
| 4 Nov 2019 – 19 Nov 2019 | Human Drugs | 483 | View 483 → |
| 15 Jan 2019 – 6 Feb 2019 | Human Drugs | 483 | On file |
| 15 Aug 2017 – 11 Sep 2017 | Human Drugs | 483 | On file |
| 10 May 2016 – 18 May 2016 | Human Drugs | Clean | |
| 9 Nov 2015 – 17 Nov 2015 | Medical Devices & Rad Health | Clean | |
| 5 May 2014 – 16 May 2014 | Human Drugs | Clean | |
| 22 Jun 2012 | Not recorded | Clean | |
| 19 Jan 2012 | Not recorded | Clean | |
| 28 Mar 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jul 2021
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Libia M Lugo, Adaliz Santaliz-Cruz, Jose F Velez
12 Jul 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Libia M Lugo, Adaliz Santaliz-Cruz, Jose F Velez
12 Jul 2021
21 CFR 211.165(d)
Acceptance criteria for sampling & testing
Cited by Libia M Lugo, Adaliz Santaliz-Cruz, Jose F Velez
12 Jul 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Libia M Lugo, Adaliz Santaliz-Cruz, Jose F Velez
12 Jul 2021
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Libia M Lugo, Adaliz Santaliz-Cruz, Jose F Velez
Investigators
FDA investigators tied to this site in the record.
Libia M Lugo5 insp.
Jose E Melendez3 insp.
Raquel Gonzalez Rivera3 insp.
Jose A Cruz Gonzalez2 insp.
Santos E Camara1 insp.
Angelica M Hernandez1 insp.
Esther C Broner1 insp.
Michal A Levine Millrod1 insp.
Adaliz Santaliz-Cruz1 insp.
Jose F Velez1 insp.
Regina T Brown1 insp.
Noreen Muniz1 insp.
Ivis L Negron Torres1 insp.
German Rivera1 insp.
Michelle Y Clark Stuart1 insp.
Min Tang1 insp.
Dayna I Martinez1 insp.
Wanda J Torres1 insp.
Annette Melendez1 insp.
Jose R Lopez1 insp.
Lourdes Andujar1 insp.
Iraida Ortiz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 10 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