Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-09-26.
At a glance
Inspections
3
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2019 – 26 Sep 2019 | Human Drugs | 483 | View 483 → |
| 10 Jun 2014 – 12 Jun 2014 | Human Drugs | Clean | |
| 13 Nov 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2019
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Emilie Kahn, Nicole A Lloyd, Michael G Truchan
26 Sep 2019
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Emilie Kahn, Nicole A Lloyd, Michael G Truchan
26 Sep 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Emilie Kahn, Nicole A Lloyd, Michael G Truchan
Investigators
FDA investigators tied to this site in the record.
Emilie Kahn1 insp.
Nicole A Lloyd1 insp.
Michael G Truchan1 insp.
Eric M Mueller1 insp.
Eric M Padgett1 insp.
Steven D Kehoe1 insp.
Jeremy W Rotton1 insp.
Matthew H Hunt1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | 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 Dynalabs, LLC'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