Overview
- 16 public-safe observations are available for this inspection.
- 15 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.
14 Jul 2010
21 CFR 108.25(c)(3)(ii)
Process information availability
Cited by Helen J Hamaoka, Ligia M Sanders
14 Jul 2010
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Helen J Hamaoka, Ligia M Sanders
14 Jul 2010
21 CFR 110.40(f)
Q.C. instrument accuracy, maintenance
Cited by Helen J Hamaoka, Ligia M Sanders
Inspected site
CGCrystal Geyser Water Company Inc.Bakersfield, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 114.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 108.25(c)(3)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 108.25(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 129.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 129.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 129.35(a)(3)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 129.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 129.80(h) | Cited across public-safe Form 483 observations | 1x |
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