Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-30.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jun 2023 – 30 Jun 2023 | Human Drugs | 483 | On file |
| 10 Sep 2019 – 19 Sep 2019 | Human Drugs | 483 | On file |
| 18 Jan 2016 – 29 Jan 2016 | Human Drugs | 483 | View 483 → |
| 13 Jan 2014 – 22 Jan 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jan 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Constance Y Fears, Barbara J Rincon
29 Jan 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Constance Y Fears, Barbara J Rincon
29 Jan 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Constance Y Fears, Barbara J Rincon
29 Jan 2016
21 CFR 211.194(a)(2)
Suitability of testing methods verified
Cited by Constance Y Fears, Barbara J Rincon
29 Jan 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Constance Y Fears, Barbara J Rincon
Investigators
FDA investigators tied to this site in the record.
Taichun Qin1 insp.
Crystal Monroy1 insp.
Joel D Hustedt1 insp.
Constance Y Fears1 insp.
Barbara J Rincon1 insp.
Sharon K Thoma1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Hainan Poly Pharm. Co., Ltd.'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