Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-05-24.
At a glance
Inspections
5
Form 483s
5
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 May 2019 – 24 May 2019 | Human Drugs | 483 | View 483 → |
| 7 Dec 2015 – 15 Dec 2015 | Human Drugs | 483 | View 483 → |
| 11 Aug 2014 – 29 Aug 2014 | Human Drugs | 483 | On file |
| 29 Jul 2014 – 29 Aug 2014 | Human Drugs | 483 | On file |
| 3 May 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
24 May 2019
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Theressa B Smith, Ruth A Williams
Investigators
FDA investigators tied to this site in the record.
Stephen T Hansen3 insp.
Teena H Aiken3 insp.
Theressa B Smith1 insp.
Ruth A Williams1 insp.
Hanna L Potter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 312.62(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Michael W. Harris, D.O.'s 5 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