Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Feb 2020
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by James R Birkenstamm, Patric C Klotzbuecher, Rose L Jean-Mary
5 Feb 2020
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by James R Birkenstamm, Patric C Klotzbuecher, Rose L Jean-Mary
5 Feb 2020
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by James R Birkenstamm, Patric C Klotzbuecher, Rose L Jean-Mary
Inspected site
OLOhm Laboratories Inc.New Brunswick, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | 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 |
Full 483 report
Get the verbatim text of all 3 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere