Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2010-05-04.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 May 2010 | Not recorded | WL | View 483 → |
| 17 Feb 2009 | Not recorded | 483 | View 483 → |
| 26 Sep 2007 | Not recorded | Clean | |
| 30 Mar 2006 | Not recorded | Clean | |
| 3 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 May 2010
21 CFR 110.10(b)(1)
Suitable outer garments
Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski
4 May 2010
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski
4 May 2010
21 CFR 110.10(b)(8)
Personal food/drink/tobacco
Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski
4 May 2010
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski
4 May 2010
21 CFR 110.35(a)
Cleaning and sanitizing operations
Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski
Investigators
FDA investigators tied to this site in the record.
Cindy W Lewis1 insp.
Mabel M Lee1 insp.
Brett W Podoski1 insp.
Quynh Strandberg1 insp.
Bruce D Broidy1 insp.
Terrence Gee1 insp.
Jenny K Yee1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Quong Hop & Co's 2 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