Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
25 Sep 2014
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by Rebecca Rodriguez
Inspected site
SGSanofi GenzymeAllston, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
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- 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