Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Feb 2019
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Elizabeth B Griffin
15 Feb 2019
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Elizabeth B Griffin
15 Feb 2019
21 CFR 630.10(f)(6)(ii)
Physical Assessment Determination - Skin Examination
Cited by Elizabeth B Griffin
Inspected site
CCCape Cod HospitalHyannis, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.41 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(f)(6)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
Every observation in full, 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