Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-04.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Aug 2023 – 4 Aug 2023 | Human Drugs | Clean | |
| 19 Aug 2019 – 23 Aug 2019 | Human Drugs | 483 | View 483 → |
| 18 Apr 2016 – 22 Apr 2016 | Human Drugs | 483 | View 483 → |
| 25 Jan 2012 | Not recorded | Clean | |
| 23 May 2011 | Not recorded | Clean | |
| 8 Feb 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Khoa Nathan V Tran1 insp.
Rowena S Nguyen1 insp.
Darren S Brown1 insp.
Bryce A Hammer1 insp.
Diane C Van Leeuwen1 insp.
Babajide M Osunsanmi1 insp.
Cntrctmntr Kelley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 11 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Calmo Manufacturing Inc's 2 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