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.
27 Oct 2010
21 CFR 812.140(b)(2)
Sponsor device disposition records inadequate
Cited by Hector J Colon-Torres
Inspected site
OPOtsuka Pharmaceutical Development & Commercialization, IncRockville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.140(b)(2) | 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