Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-09-20.
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 |
|---|---|---|---|
| 13 Sep 2022 – 20 Sep 2022 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2022
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Lavender M Huskey
20 Sep 2022
21 CFR 111.260(l)(1)
Batch record - quality control review; production
Cited by Lavender M Huskey
Investigators
FDA investigators tied to this site in the record.
Lavender M Huskey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BioNativus Inc.'s 1 Form 483
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