Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-18.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Sep 2023 – 18 Sep 2023 | Human Drugs | 483 | On file |
| 23 Jul 2015 – 24 Jul 2015 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jul 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Lucas B Leake
Investigators
FDA investigators tied to this site in the record.
Dipesh K Shah1 insp.
Lucas B Leake1 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 | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.60(e) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind DKR Labs Analytical Services' 2 Form 483s
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