Overview
- 16 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-31.
At a glance
Inspections
16
Form 483s
11
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 May 2023 – 31 May 2023 | Human Drugs | 483 | View 483 → |
| 6 Mar 2018 – 15 Mar 2018 | Human Drugs | 483 | View 483 → |
| 4 Oct 2016 – 24 Oct 2016 | Human Drugs | 483 | On file |
| 16 Nov 2015 – 19 Nov 2015 | Human Drugs | Clean | |
| 7 May 2015 – 22 May 2015 | Human Drugs | 483 | View 483 → |
| 7 May 2015 – 11 May 2015 | Human Drugs | 483 | On file |
| 13 Aug 2013 – 9 Sep 2013 | Human Drugs | 483 | On file |
| 20 Mar 2013 – 24 Apr 2013 | Human Drugs | 483 | On file |
| 7 Jun 2012 | Not recorded | 483 | On file |
| 24 Feb 2011 | Not recorded | 483 | View 483 → |
| 29 Mar 2010 | Not recorded | 483 | View 483 → |
| 27 Feb 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 May 2023
21 CFR 211.165(b)
Microbiological testing
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
31 May 2023
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
15 Mar 2018
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Vilmary Negron Rodriguez, Jose A Lopez Rubet, Marian E Ramirez, Jose R Flores-Veguilla
15 Mar 2018
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Vilmary Negron Rodriguez, Jose A Lopez Rubet, Marian E Ramirez, Jose R Flores-Veguilla
15 Mar 2018
21 CFR 211.67(b)(3)
Cleaning SOPs/instructions
Cited by Vilmary Negron Rodriguez, Jose A Lopez Rubet, Marian E Ramirez, Jose R Flores-Veguilla
Investigators
FDA investigators tied to this site in the record.
Marian E Ramirez3 insp.
Jose A Lopez Rubet3 insp.
Libia M Lugo3 insp.
Laurimer Kuilan-Torres2 insp.
Miguel A Martinez2 insp.
Dayna I Martinez2 insp.
Angelica M Hernandez1 insp.
Alan A Rivera1 insp.
Vilmary Negron Rodriguez1 insp.
Jose R Flores-Veguilla1 insp.
Joan M Cantellops Figueroa1 insp.
Cheryl A Clausen1 insp.
Jose F Velez1 insp.
Loreily Figueroa Agrinsoni1 insp.
Jose R Lopez1 insp.
Jose E Melendez1 insp.
Jorge L Lajara1 insp.
Iraida Ortiz1 insp.
Ivis L Negron Torres1 insp.
Milva E Melendez1 insp.
Rebecca Parrilla1 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 | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 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 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(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)(4) | 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)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Auro PR Inc.'s 11 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