Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
18 Dec 2018
21 CFR 1.504(b)(1)
Hazard analysis biological, chemical, physical
Cited by Willy A Orantes, Spiridoula Dimopoulos, William Leung
18 Dec 2018
21 CFR 1.505(a)(2)
Evaluation - performance, risk
Cited by Willy A Orantes, Spiridoula Dimopoulos, William Leung
18 Dec 2018
21 CFR 1.505(b)
Supplier approval - document
Cited by Willy A Orantes, Spiridoula Dimopoulos, William Leung
18 Dec 2018
21 CFR 1.506(a)(1)
Procedures - establish, approve supplier
Cited by Willy A Orantes, Spiridoula Dimopoulos, William Leung
18 Dec 2018
21 CFR 1.506(e)(1)(iv)(B)
Verification activity - document
Cited by Willy A Orantes, Spiridoula Dimopoulos, William Leung
Inspected site
FIFabi-saa Inc.Newark, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.504(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(e)(1)(iv)(B) | 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