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.
19 Dec 2017
21 CFR 117.165(b)
Process Controls Verif Procedures: Establish Implement
Cited by Darren S Morgan, Dorathy M Eischen
Inspected site
AIApio, Inc.Bowling Green, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
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- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere