Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-05.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Sep 2024 – 5 Sep 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Oct 2017 – 12 Oct 2017 | Medical Devices & Rad Health | 483 | On file |
| 11 Apr 2016 – 14 Apr 2016 | Medical Devices & Rad Health | Clean | |
| 17 Mar 2014 – 20 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Aug 2012 | Not recorded | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Sep 2024
21 CFR 820.250(b)
Sampling methods - Lack of or inadequate procedures
Cited by Daniel J Lahar
Investigators
FDA investigators tied to this site in the record.
Daniel J Lahar1 insp.
MDSAP WilliamsA1 insp.
Meredith L Sheridan1 insp.
Marc S Neubauer1 insp.
Catherine J Laufmann1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GUANGDONG BIOLIGHT MEDITECH 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