Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Nov 2024
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Gary C Pecic, Tomanik'E C Banks, Jacqueline O Snell, Tomanik'E C Howard
6 Nov 2024
21 CFR 111.315(d)
Standard reference materials; criteria for selecting
Cited by Gary C Pecic, Tomanik'E C Banks, Jacqueline O Snell, Tomanik'E C Howard
6 Nov 2024
21 CFR 111.320(b)
Examination, testing; scientifically valid
Cited by Gary C Pecic, Tomanik'E C Banks, Jacqueline O Snell, Tomanik'E C Howard
6 Nov 2024
21 CFR 111.605
Records - keep: 1 year, 2 years
Cited by Gary C Pecic, Tomanik'E C Banks, Jacqueline O Snell, Tomanik'E C Howard
6 Nov 2024
21 CFR 111.70(b)
Specifications - components
Cited by Gary C Pecic, Tomanik'E C Banks, Jacqueline O Snell, Tomanik'E C Howard
Inspected site
BIBestvite, Inc.Sun Valley, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.605 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, 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