Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
7 Apr 2023
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Mohamad A Chahine, Christopher R Richardson
7 Apr 2023
21 CFR 117.135(a)(1)
Process preventive controls - Implement
Cited by Mohamad A Chahine, Christopher R Richardson
7 Apr 2023
21 CFR 117.410(c)
Supply-chain program - Assurance (Adequate)
Cited by Mohamad A Chahine, Christopher R Richardson
Inspected site
EPEight P CPL, LLCElkridge, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.410(c) | 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