Overview
- 18 public-safe observations are available for this inspection.
- 8 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.
4 May 2015
21 CFR 120.10(a)
Corrective action - predetermined plan
Cited by Jazmine M Welcher, Helen J Hamaoka, Carrie E Thrasher
4 May 2015
21 CFR 120.11(a)(1)
Verification activities - minimum
Cited by Jazmine M Welcher, Helen J Hamaoka, Carrie E Thrasher
4 May 2015
21 CFR 120.11(a)(1)(iv)(A)
CCP record review adequacy
Cited by Jazmine M Welcher, Helen J Hamaoka, Carrie E Thrasher
4 May 2015
21 CFR 120.12(a)
Records required - not maintained
Cited by Jazmine M Welcher, Helen J Hamaoka, Carrie E Thrasher
4 May 2015
21 CFR 120.12(b)
Records - general - include name, date, time
Cited by Jazmine M Welcher, Helen J Hamaoka, Carrie E Thrasher
Inspected site
GEGrimmway Enterprises Inc.Arvin, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 120.12(b)(4) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 120.10(a) | 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)(A) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.12(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.12(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.24(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.6(b) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 18 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