Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 Jun 2022
21 CFR 1.511(c)(2)(ii)
No CGMPs - procedures, foreign supplier, another entity
Cited by Bryce H Thompson, Shawn G Lavene
Inspected site
IOIMS OF WESTERN NYBuffalo, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.511(c)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
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