Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-06-19.
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 Jun 2018 – 19 Jun 2018 | Human Drugs | 483 | View 483 → |
| 12 May 2016 – 20 May 2016 | Human Drugs | 483 | On file |
| 10 Mar 2014 – 18 Mar 2014 | Human Drugs | 483 | View 483 → |
| 8 Jul 2011 | Not recorded | Clean | |
| 21 Jan 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Jun 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Rachael A Moliver, Katie L Penno
Investigators
FDA investigators tied to this site in the record.
Rachael A Moliver1 insp.
Katie L Penno1 insp.
Constance Y Fears1 insp.
Luis A Dasta1 insp.
Noreen Muniz1 insp.
Salvatore N Randazzo1 insp.
Edwin Melendez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(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