Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-01-31.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jan 2018 – 31 Jan 2018 | Biologics | 483 | View 483 → |
| 2 Mar 2016 – 18 Mar 2016 | Biologics | 483 | View 483 → |
| 8 May 2014 – 12 May 2014 | Biologics | Clean | |
| 25 Sep 2012 | Not recorded | 483 | View 483 → |
| 28 Sep 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Irina Gaberman3 insp.
Amy Kim1 insp.
Kellie Leveille1 insp.
Mercedes G Castillo1 insp.
Evelyn Taha1 insp.
Yvonne M Santiago1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.55(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.85(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 Form 483s
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