FDA Inspection
Waveform IncWaveform Inc – FDA Inspection, Mar 9, 2011
Record Details
This FDA Inspection record concerns Waveform Inc, with an inspection on March 9, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Waveform Inc
- Inspection Date
- March 9, 2011
- Product Type
- Drugs
View Company Profile
ID · 013a3498-f7e5-4645-87fd-0aef1176fc54
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 713436
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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Other FDA inspections of Waveform Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Waveform Inc
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