Overview
- 8 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-07-02.
At a glance
Inspections
8
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jun 2021 – 2 Jul 2021 | Human Drugs | 483 | View 483 → |
| 3 Mar 2020 – 10 Mar 2020 | Human Drugs | 483 | View 483 → |
| 21 Feb 2019 – 6 Mar 2019 | Human Drugs | 483 | View 483 → |
| 19 Mar 2018 – 23 Mar 2018 | Human Drugs | 483 | On file |
| 29 Feb 2016 – 23 Mar 2016 | Human Drugs | 483 | On file |
| 4 Aug 2015 – 14 Aug 2015 | Human Drugs | 483 | On file |
| 22 Oct 2012 | Not recorded | 483 | View 483 → |
| 10 Dec 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Jul 2021
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Ivis L Negron Torres, Marian E Ramirez
2 Jul 2021
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Ivis L Negron Torres, Marian E Ramirez
2 Jul 2021
21 CFR 211.160(b)(4)
Written calibration procedures
Cited by Ivis L Negron Torres, Marian E Ramirez
2 Jul 2021
21 CFR 211.166(a)
Written program not followed
Cited by Ivis L Negron Torres, Marian E Ramirez
2 Jul 2021
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Ivis L Negron Torres, Marian E Ramirez
Investigators
FDA investigators tied to this site in the record.
Jose F Velez4 insp.
Ivis L Negron Torres3 insp.
Marian E Ramirez3 insp.
Noreen Muniz1 insp.
Zhongren Wu1 insp.
Dewayne E Whitlock1 insp.
Edwin Martinez1 insp.
Jose R Lopez1 insp.
Libia M Lugo1 insp.
Javier O Vega1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site'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