Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-11-06.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Oct 2023 – 6 Nov 2023 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Nov 2023
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by William R Chang, Monica L Gutierrez, Naakesh N Gomanie
6 Nov 2023
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by William R Chang, Monica L Gutierrez, Naakesh N Gomanie
6 Nov 2023
21 CFR 820.22
Quality Audit/Reaudit - conducted
Cited by William R Chang, Monica L Gutierrez, Naakesh N Gomanie
6 Nov 2023
21 CFR 820.30(b)
Design plans - Lack of or inadequate
Cited by William R Chang, Monica L Gutierrez, Naakesh N Gomanie
6 Nov 2023
21 CFR 820.30(c)
Design input - documentation
Cited by William R Chang, Monica L Gutierrez, Naakesh N Gomanie
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | 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 Biocore9 Llc's 1 Form 483
Source PDFs 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