Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-10-27.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Oct 2021 – 27 Oct 2021 | Human Drugs | 483 | View 483 → |
| 6 Feb 2017 – 10 Feb 2017 | Human Drugs | 483 | View 483 → |
| 6 Sep 2012 | Not recorded | 483 | On file |
| 11 Feb 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Oct 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Dogbeda F Mackenzie, Matthew R Clabeaux
27 Oct 2021
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Dogbeda F Mackenzie, Matthew R Clabeaux
27 Oct 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Dogbeda F Mackenzie, Matthew R Clabeaux
27 Oct 2021
21 CFR 211.194(a)(6)
Comparison of Test Results to Specifications
Cited by Dogbeda F Mackenzie, Matthew R Clabeaux
27 Oct 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Dogbeda F Mackenzie, Matthew R Clabeaux
Investigators
FDA investigators tied to this site in the record.
Dogbeda F Mackenzie1 insp.
Matthew R Clabeaux1 insp.
Nayan J Patel1 insp.
Jamie L Dion1 insp.
Edith M Gonzalez1 insp.
Isabel Y Espinosa1 insp.
Caroline H Le1 insp.
Linda M Cherry1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bioelements, Inc's 3 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