Overview
- 7 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Apr 2022
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Taichun Qin, James B Arnett
15 Apr 2022
21 CFR 211.165(a)
Testing and release for distribution
Cited by Taichun Qin, James B Arnett
15 Apr 2022
FDCA 501(a)(2)(A)
Hazardous drugs, prevention of cross-contamination
Cited by Taichun Qin, James B Arnett
Inspected site
LOLynn Oaks Compounding PharmacyThousand Oaks, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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