Overview
- 4 public-safe observations are available for this inspection.
- 2 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.
16 Aug 2016
21 CFR 118.10(b)(3)
Signature and date on SE plans
Cited by Osama M Hamoud, Nina D Patel, Collins M Mason
16 Aug 2016
21 CFR 118.4
No written SE prevention plan
Cited by Osama M Hamoud, Nina D Patel, Collins M Mason
16 Aug 2016
21 CFR 118.4
Written SE plan lacks required elements
Cited by Osama M Hamoud, Nina D Patel, Collins M Mason
16 Aug 2016
21 CFR 118.4
Written SE plan not implemented/followed
Cited by Osama M Hamoud, Nina D Patel, Collins M Mason
Inspected site
JPJared Petre #21Williamsport, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 118.4 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 118.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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