FDA Inspection
Waveform IncWaveform Inc – FDA Inspection, Oct 29, 2015
Record Details
This FDA Inspection record concerns Waveform Inc, with an inspection on October 29, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Waveform Inc
- Inspection Date
- October 29, 2015
- Product Type
- Drugs
View Company Profile
ID · bed9ae37-a983-4ddd-a336-fc92ec1309d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 948557
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(b)Written sanitation procedures not followed
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Waveform Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Waveform Inc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.