FDA Inspection
Tribute LabsTribute Labs – FDA Inspection, Oct 21, 2015
Record Details
This FDA Inspection record concerns Tribute Labs, with an inspection on October 21, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tribute Labs
- Inspection Date
- October 21, 2015
- Product Type
- Drugs
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ID · 8929e684-bba1-40f8-b3ae-eaff2057a4c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946177
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.192No written record of investigation
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