Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-12-01.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2021 – 1 Dec 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Nov 2019 – 26 Nov 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Feb 2017 | Medical Devices & Rad Health | Clean | |
| 15 Jul 2013 – 18 Jul 2013 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Dec 2021
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by Jennifer S Ness
1 Dec 2021
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Jennifer S Ness
Investigators
FDA investigators tied to this site in the record.
Jennifer S Ness1 insp.
Susan M Matthias1 insp.
Marissa S Steinhagen1 insp.
Yehualashe A Gessesse1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 809.10(b)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Microbiologics Inc's 2 Form 483s
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