Overview
- 16 public-safe observations are available for this inspection.
- 8 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.
24 Jul 2015
21 CFR 120.11(a)(1)
Verification activities - minimum
Cited by Laura B Kennedy, Kristen E Szenderski
24 Jul 2015
21 CFR 120.11(a)(1)(iv)
Records - not signed and dated by qualified individual
Cited by Laura B Kennedy, Kristen E Szenderski
24 Jul 2015
21 CFR 120.12(b)
Records - general - include name, date, time
Cited by Laura B Kennedy, Kristen E Szenderski
24 Jul 2015
21 CFR 120.8(b)(1)
HACCP plan - food hazards not listed
Cited by Laura B Kennedy, Kristen E Szenderski
24 Jul 2015
21 CFR 120.8(b)(2)
HACCP plan - critical control points not listed
Cited by Laura B Kennedy, Kristen E Szenderski
Inspected site
BIBhakti, Inc.Westminster, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 120.10(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.11(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.11(a)(1)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.12(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.6(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.8(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.8(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.8(b)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 16 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