Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-07.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Oct 2024 – 7 Nov 2024 | Human Drugs | 483 | On file |
| 25 Mar 2024 – 2 Apr 2024 | Human Drugs | 483 | View 483 → |
| 7 Jun 2022 – 16 Jun 2022 | Human Drugs | 483 | On file |
| 29 Oct 2018 – 6 Nov 2018 | Human Drugs | 483 | On file |
| 28 Aug 2017 – 5 Sep 2017 | Human Drugs | 483 | View 483 → |
| 16 Apr 2015 – 24 Apr 2015 | Human Drugs | 483 | On file |
| 22 Aug 2013 – 30 Aug 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by James R Birkenstamm, Amir Alavi
2 Apr 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by James R Birkenstamm, Amir Alavi
2 Apr 2024
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by James R Birkenstamm, Amir Alavi
2 Apr 2024
21 CFR 211.68(b)
Computer control of master formula records
Cited by James R Birkenstamm, Amir Alavi
Investigators
FDA investigators tied to this site in the record.
Thuy T Nguyen1 insp.
Liqun Zhao1 insp.
Mia J Chang1 insp.
Karthik M Krishnan1 insp.
James R Birkenstamm1 insp.
Amir Alavi1 insp.
Bo Chi1 insp.
Rita K Kabaso1 insp.
Satheesh Thomas1 insp.
Michael A Charles1 insp.
Marie B Buen-Bigornia1 insp.
Barbara J Breithaupt1 insp.
Dandan Wang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nang Kuang Pharmaceutical Co. Ltd.'s 7 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