Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-22.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2024 – 22 Mar 2024 | Human Drugs | 483 | On file |
| 5 Aug 2019 – 9 Aug 2019 | Human Drugs | 483 | On file |
| 21 Jan 2019 – 25 Jan 2019 | Human Drugs | 483 | View 483 → |
| 12 Mar 2018 – 16 Mar 2018 | Human Drugs | Clean | |
| 16 Oct 2017 – 19 Oct 2017 | Human Drugs | 483 | On file |
| 22 Sep 2015 – 25 Sep 2015 | Human Drugs | 483 | On file |
| 10 Mar 2014 – 14 Mar 2014 | Human Drugs | Clean | |
| 21 Apr 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Peter E Baker2 insp.
Ephrem T Hunde1 insp.
Tekalign Wondimu1 insp.
Kara D Dobbin1 insp.
Ruo H Xu1 insp.
Roger F Zabinski1 insp.
Qin Xu1 insp.
Christopher T Middendorf1 insp.
Timothy T Kapsala1 insp.
Simone E Pitts1 insp.
Dongping Dai1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Sunshine Lake Pharma Co., Ltd.'s 6 Form 483s
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