Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
7 Feb 2013
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Bichsa T Tran, Caryn M Mcnab
7 Feb 2013
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Bichsa T Tran, Caryn M Mcnab
7 Feb 2013
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Bichsa T Tran, Caryn M Mcnab
7 Feb 2013
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Bichsa T Tran, Caryn M Mcnab
7 Feb 2013
21 CFR 211.68(a)
Written calibration / inspection records not kept
Cited by Bichsa T Tran, Caryn M Mcnab
Inspected site
AAAdamson Analytical Laboratories, Inc.Corona, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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