Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-06-21.
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 |
|---|---|---|---|
| 14 Jun 2018 – 21 Jun 2018 | Human Drugs | 483 | On file |
| 26 Jun 2017 – 30 Jun 2017 | Human Drugs | 483 | On file |
| 2 Nov 2015 – 10 Nov 2015 | Human Drugs | 483 | View 483 → |
| 16 Sep 2011 | Not recorded | 483 | On file |
| 19 Sep 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Nov 2015
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Christophe T Peters, Chad N Thompson
10 Nov 2015
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Christophe T Peters, Chad N Thompson
10 Nov 2015
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Christophe T Peters, Chad N Thompson
10 Nov 2015
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Christophe T Peters, Chad N Thompson
10 Nov 2015
21 CFR 211.160(b)(4)
Instruments, apparatus, et. al. not meeting specs
Cited by Christophe T Peters, Chad N Thompson
Investigators
FDA investigators tied to this site in the record.
Jose A Cruz Gonzalez1 insp.
Lauren N Howard1 insp.
Allison A Aldridge1 insp.
Lauren N Smith1 insp.
Christophe T Peters1 insp.
Chad N Thompson1 insp.
Sandra A Hughes1 insp.
Steven C Madzo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(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 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alfasigma 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