Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-12.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Sep 2024 | Foods & Cosmetics | Clean | |
| 21 Feb 2024 – 23 Feb 2024 | Human Drugs | 483 | On file |
| 4 Apr 2023 – 12 Apr 2023 | Human Drugs | WL | View 483 → |
| 27 Apr 2021 – 29 Apr 2021 | Human Drugs | 483 | View 483 → |
| 22 Jun 2015 – 25 Jun 2015 | Human Drugs | 483 | View 483 → |
| 20 Mar 2012 | Not recorded | 483 | View 483 → |
| 29 Nov 2010 | Not recorded | 483 | On file |
| 17 Nov 2009 | Not recorded | Clean | |
| 7 Mar 2007 | Not recorded | Clean | |
| 5 Apr 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Apr 2023
21 CFR 211.166(a)
Lack of written stability program
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
12 Apr 2023
21 CFR 211.180(e)
Records reviewed annually
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
12 Apr 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
12 Apr 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
12 Apr 2023
21 CFR 211.63
Equipment Design, Size and Location
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
Investigators
FDA investigators tied to this site in the record.
Saied A Asbagh2 insp.
Liming Zhang2 insp.
Geoffrey M Leist1 insp.
Lena Nguyen1 insp.
Thuy Tram L Nguyen1 insp.
Khoa Nathan V Tran1 insp.
Lillian S Wu1 insp.
Rowena S Nguyen1 insp.
Caryn M Mcnab1 insp.
Zachary A Bogorad1 insp.
Andy B Lee1 insp.
John A Gonzalez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind COLONIAL DAMES CO LTD's 6 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