Overview
- 8 public-safe observations are available for this inspection.
- 6 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.
5 May 2015
21 CFR 113.100(a)
Process records - not done; not timely
Cited by Raymond L Cheung, Jo-Ann C Declement
5 May 2015
21 CFR 113.100(b)
Review of processing and production records
Cited by Raymond L Cheung, Jo-Ann C Declement
Inspected site
D&DiLullo & SonsWestville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 113.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.100(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(a)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.89 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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