Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-10-28.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Oct 2021 | Biologics | Clean | |
| 6 Sep 2018 | Biologics | Clean | |
| 15 Jun 2016 | Biologics | Clean | |
| 17 Jul 2014 | Biologics | Clean | |
| 21 Feb 2012 | Not recorded | 483 | View 483 → |
| 13 Nov 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Feb 2012
21 CFR 606.40(a)(1)
Provide space for examination
Cited by Annette Melendez, Juan R Jimenez Garcia
21 Feb 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Annette Melendez, Juan R Jimenez Garcia
Investigators
FDA investigators tied to this site in the record.
Laura E Garcia2 insp.
Annette Melendez2 insp.
German Rivera1 insp.
Juan R Jimenez Garcia1 insp.
Frances L Dejesus1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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