Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-06.
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 |
|---|---|---|---|
| 28 Nov 2022 – 6 Dec 2022 | Human Drugs | 483 | View 483 → |
| 12 Sep 2019 – 20 Sep 2019 | Human Drugs | 483 | View 483 → |
| 14 Nov 2016 – 22 Nov 2016 | Human Drugs | 483 | View 483 → |
| 5 May 2014 – 13 May 2014 | Human Drugs | WL | View 483 → |
| 9 Nov 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2022
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by William J Leonard
Investigators
FDA investigators tied to this site in the record.
William J Leonard1 insp.
Marcus F Yambot1 insp.
June P Page1 insp.
Marie B Buen-Bigornia1 insp.
Lynda L Perry1 insp.
Justin A Boyd1 insp.
Ralph H Vocque1 insp.
James C Maclaughlin1 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 | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 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 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Avara Liscate Pharmaceutical Services SPA's 4 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