Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-11-07.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Nov 2019 – 7 Nov 2019 | Medical Devices & Rad Health | Clean | |
| 27 Sep 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Sep 2012
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Christine M Parmentier
27 Sep 2012
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Christine M Parmentier
27 Sep 2012
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Christine M Parmentier
Investigators
FDA investigators tied to this site in the record.
Christina L Bigham1 insp.
Christine M Parmentier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bistos Co Ltd's 1 Form 483
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