Overview
- 12 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-30.
At a glance
Inspections
12
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jan 2025 – 30 Jan 2025 | Human Drugs | 483 | On file |
| 6 Nov 2023 – 13 Nov 2023 | Medical Devices & Rad Health | 483 | On file |
| 5 Dec 2022 – 19 Dec 2022 | Human Drugs | 483 | View 483 → |
| 7 Sep 2021 – 20 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jun 2017 – 10 Jul 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Oct 2014 – 12 Nov 2014 | Human Drugs | 483 | View 483 → |
| 26 Aug 2013 – 30 Aug 2013 | Medical Devices & Rad Health | 483 | On file |
| 8 Nov 2011 | Not recorded | Clean | |
| 31 May 2011 | Not recorded | Clean | |
| 20 Aug 2009 | Not recorded | Clean | |
| 6 Aug 2008 | Not recorded | 483 | On file |
| 16 Jan 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Dec 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Shafiq Ahadi, Simone E Pitts, Joseph A Piechocki
19 Dec 2022
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Shafiq Ahadi, Simone E Pitts, Joseph A Piechocki
19 Dec 2022
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Shafiq Ahadi, Simone E Pitts, Joseph A Piechocki
19 Dec 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Shafiq Ahadi, Simone E Pitts, Joseph A Piechocki
19 Dec 2022
21 CFR 211.194(a)(4)
Data secured in course of each test
Cited by Shafiq Ahadi, Simone E Pitts, Joseph A Piechocki
Investigators
FDA investigators tied to this site in the record.
Nicholas Z Lu2 insp.
Jesse A Vazquez2 insp.
Christopher D Leach2 insp.
Stephen D Eich2 insp.
Robert J Ham1 insp.
Joohi Castelvetere1 insp.
Mary L Schuckmann1 insp.
Anders W Evenson1 insp.
Shafiq Ahadi1 insp.
Simone E Pitts1 insp.
Joseph A Piechocki1 insp.
Michele L Glendenning1 insp.
That Q Dang1 insp.
Paul L Bellamy1 insp.
Patricia A Mcilroy1 insp.
Nicholas P Diorio1 insp.
Jennifer C Johnson1 insp.
James W Plucinski1 insp.
Paola S Barnett1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | 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 211.46(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amsino Healthcare (USA) Inc.'s 8 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