Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-18.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Aug 2023 – 18 Aug 2023 | Human Drugs | 483 | View 483 → |
| 16 Jul 2018 – 19 Jul 2018 | Human Drugs | 483 | On file |
| 9 Mar 2015 – 13 Mar 2015 | Human Drugs | 483 | On file |
| 2 Sep 2011 | Not recorded | 483 | On file |
| 12 Sep 2008 | Not recorded | 483 | On file |
| 16 Mar 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Aug 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Hung H Do, Rowena S Nguyen
18 Aug 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Hung H Do, Rowena S Nguyen
18 Aug 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Hung H Do, Rowena S Nguyen
18 Aug 2023
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Hung H Do, Rowena S Nguyen
18 Aug 2023
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Hung H Do, Rowena S Nguyen
Investigators
FDA investigators tied to this site in the record.
Hung H Do1 insp.
Rowena S Nguyen1 insp.
Junho Pak1 insp.
Steven D Kehoe1 insp.
Minh D Phan1 insp.
Susan F Laska1 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 | 3x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Guilin Pharmaceutical Co., Ltd.'s 5 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