Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-04.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 May 2025 – 4 Jun 2025 | Human Drugs | 483 | View 483 → |
| 20 Apr 2022 – 22 Apr 2022 | Human Drugs | 483 | View 483 → |
| 23 Aug 2017 – 25 Aug 2017 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Jun 2025
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Jennifer Lalama, Mickell Smith
4 Jun 2025
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Jennifer Lalama, Mickell Smith
22 Apr 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Joanne E King, Kayla V Sprague
Investigators
FDA investigators tied to this site in the record.
Jennifer Lalama1 insp.
Mickell Smith1 insp.
Joanne E King1 insp.
Kayla V Sprague1 insp.
Adam R Cooke1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kappa Laboratories, Inc.'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