FDA Inspection
Waveform IncWaveform Inc – FDA Inspection, Feb 19, 2016
Record Details
This FDA Inspection record concerns Waveform Inc, with an inspection on February 19, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Waveform Inc
- Inspection Date
- February 19, 2016
- Product Type
- Drugs
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ID · 31c8454e-b2b0-4d2c-8928-02f69a882feb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 961404
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.101(d)Component release checked by 2nd person
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
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