Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-11-03.
At a glance
Inspections
10
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Oct 2021 – 3 Nov 2021 | Human Drugs | WL | On file |
| 30 Aug 2018 – 14 Sep 2018 | Human Drugs | 483 | View 483 → |
| 11 Jan 2016 – 12 Feb 2016 | Human Drugs | 483 | View 483 → |
| 25 Feb 2013 – 20 Mar 2013 | Human Drugs | 483 | View 483 → |
| 19 Jul 2011 | Not recorded | 483 | On file |
| 7 May 2010 | Not recorded | 483 | View 483 → |
| 19 Aug 2009 | Not recorded | 483 | View 483 → |
| 27 Jan 2005 | Not recorded | Clean | |
| 15 Feb 2001 | Not recorded | Clean | |
| 10 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Sep 2018
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Santos E Camara, Jose F Velez
14 Sep 2018
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Santos E Camara, Jose F Velez
14 Sep 2018
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Santos E Camara, Jose F Velez
14 Sep 2018
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Santos E Camara, Jose F Velez
14 Sep 2018
21 CFR 211.165(a)
Testing and release for distribution
Cited by Santos E Camara, Jose F Velez
Investigators
FDA investigators tied to this site in the record.
Jose F Velez2 insp.
Karl D Hezel2 insp.
Dayna I Martinez2 insp.
Ariel Cruz Figueroa1 insp.
Santos E Camara1 insp.
Patric C Klotzbuecher1 insp.
Edwin Martinez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.315(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.110(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.260(l)(1)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.44 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.82(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Agropharma Laboratories Inc.'s 7 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