Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-12-13.
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 |
|---|---|---|---|
| 11 Dec 2018 – 13 Dec 2018 | Human Drugs | 483 | View 483 → |
| 13 Jun 2016 – 15 Jun 2016 | Biologics | Clean | |
| 12 May 2015 – 14 May 2015 | Human Drugs | 483 | On file |
| 11 Dec 2013 – 13 Dec 2013 | Human Drugs | 483 | On file |
| 5 Nov 2013 – 8 Nov 2013 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Dec 2018
21 CFR 212.30(a)
Orderly handling, prevention of mix-ups, prevention of contamination
Cited by Zachary A Bogorad, Nicholas L Hunt, Kenneth O Gee
13 Dec 2018
21 CFR 212.40(c)
Each lot identified and tested
Cited by Zachary A Bogorad, Nicholas L Hunt, Kenneth O Gee
13 Dec 2018
21 CFR 212.50
Adequate controls (general)
Cited by Zachary A Bogorad, Nicholas L Hunt, Kenneth O Gee
13 Dec 2018
21 CFR 212.60(g)
Test records complete (general)
Cited by Zachary A Bogorad, Nicholas L Hunt, Kenneth O Gee
Investigators
FDA investigators tied to this site in the record.
Lance M De Souza2 insp.
Zachary A Bogorad1 insp.
Nicholas L Hunt1 insp.
Kenneth O Gee1 insp.
Lynn L Wong1 insp.
Jennifer H Rhyu1 insp.
Kenneth Boehnen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hamamatsu / Queens PET Imaging Center, LLC's 4 Form 483s
Source PDFs 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