Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
2 Jul 2009
21 CFR 123.6(c)(3)
Critical limits
Cited by Slater K Bartlett, Robert J Martin, Christopher M Elliott
2 Jul 2009
21 CFR 123.6(c)(4)
Monitoring - adequacy
Cited by Slater K Bartlett, Robert J Martin, Christopher M Elliott
2 Jul 2009
21 CFR 123.6(c)(5)
Corrective action plan
Cited by Slater K Bartlett, Robert J Martin, Christopher M Elliott
2 Jul 2009
21 CFR 123.6(c)(6)
Verification procedures - adequacy
Cited by Slater K Bartlett, Robert J Martin, Christopher M Elliott
2 Jul 2009
21 CFR 123.11(b)
Sanitation monitoring documentation
Cited by Slater K Bartlett, Robert J Martin, Christopher M Elliott
Inspected site
SGSLADE GORTON & CO., INC.Waltham, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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