Overview
- 2 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Jun 2016
21 CFR 123.12(a)(2)
Importer verification
Cited by Jorge L Lajara, Marian E Ramirez, Sandra Carpio, CntrctMntr CarpioS
2 Jun 2016
21 CFR 123.12(a)(2)
Importer verification
Cited by Jorge L Lajara, Marian E Ramirez, Sandra Carpio, CntrctMntr CarpioS
Inspected site
JSJose Santiago, Inc.Bayamon, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 2 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