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.
25 Aug 2016
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Travis S Bradley, Brittany M Lowe
Inspected site
QDQuest DiagnosticsIndianapolis, United States
Inspection team
BMBrittany M Lowe
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
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- The investigators involved and the citations they repeat elsewhere