Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-12-10.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Dec 2014 – 10 Dec 2014 | Human Drugs | Clean | |
| 10 Aug 2012 | Not recorded | 483 | View 483 → |
| 21 Jan 2010 | Not recorded | 483 | On file |
| 19 Jun 2008 | Not recorded | WL | On file |
| 10 Nov 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Aug 2012
21 CFR 212.20(d)
Determination need for investigation
Cited by Kenneth H Williams, Philip F Istafanos, Charisse K Green, Paul C Mouris, Valentino Fiorella, Kazi Rafiquzzaman
10 Aug 2012
21 CFR 212.40(a)
Suitable for intended use
Cited by Kenneth H Williams, Philip F Istafanos, Charisse K Green, Paul C Mouris, Valentino Fiorella, Kazi Rafiquzzaman
10 Aug 2012
21 CFR 212.60(b)
Testing Procedures- Conformance to Standards
Cited by Kenneth H Williams, Philip F Istafanos, Charisse K Green, Paul C Mouris, Valentino Fiorella, Kazi Rafiquzzaman
Investigators
FDA investigators tied to this site in the record.
Paul C Mouris2 insp.
Robert C Horan1 insp.
Kenneth H Williams1 insp.
Philip F Istafanos1 insp.
Charisse K Green1 insp.
Valentino Fiorella1 insp.
Kazi Rafiquzzaman1 insp.
Sony Mathews1 insp.
Robert C Steyert1 insp.
Gary J Lehr1 insp.
Dennis E Guilfoyle1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Columbia Presbyterian Medical Center's 3 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