Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-04.
At a glance
Inspections
5
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Oct 2025 – 4 Nov 2025 | Human Drugs | Clean | |
| 27 Jul 2021 – 6 Aug 2021 | Human Drugs | 483 | View 483 → |
| 11 Jun 2018 – 19 Jun 2018 | Medical Devices & Rad Health | Clean | |
| 15 May 2013 – 17 May 2013 | Human Drugs | 483 | View 483 → |
| 4 Dec 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Aug 2021
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Alice S Tsao, Alexander V Gontcharov
6 Aug 2021
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Alice S Tsao, Alexander V Gontcharov
4 Dec 2009
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Maya M Davis, Mark R Mcclain, Diane C Thibodeau
Investigators
FDA investigators tied to this site in the record.
Maya M Davis2 insp.
JoshRenzo N Ramilo1 insp.
Alice S Tsao1 insp.
Alexander V Gontcharov1 insp.
Robert J Martin1 insp.
Mark R Mcclain1 insp.
Diane C Thibodeau1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MannKind Corporation'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