Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-16.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 May 2023 – 16 May 2023 | Human Drugs | 483 | View 483 → |
| 26 Feb 2019 – 1 Mar 2019 | Human Drugs | Clean | |
| 10 Jul 2017 – 18 Jul 2017 | Human Drugs | Clean | |
| 16 Nov 2015 – 20 Nov 2015 | Human Drugs | Clean | |
| 27 Jun 2013 – 4 Jul 2013 | Human Drugs | 483 | On file |
| 10 May 2010 | Not recorded | 483 | View 483 → |
| 11 Jul 2008 | Not recorded | 483 | On file |
| 29 Mar 2006 | Not recorded | Clean | |
| 24 Mar 2005 | Not recorded | Clean | |
| 23 Sep 2003 | Not recorded | Clean | |
| 29 May 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Mindy M Chou, Brandy N Lepage
16 May 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Mindy M Chou, Brandy N Lepage
10 May 2010
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles
Investigators
FDA investigators tied to this site in the record.
Mindy M Chou1 insp.
Brandy N Lepage1 insp.
MRA DavisM1 insp.
Samina S Khan1 insp.
Anastasia M Shields1 insp.
Sangeeta M Khurana1 insp.
Steven P Donald1 insp.
S. L Brown1 insp.
Steven C Madzo1 insp.
Michael A Charles1 insp.
Susan M Jackson1 insp.
Regina T Brown1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 |
Full site report
Get the verbatim findings behind ACS Dobfar SpA'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