FDA Inspection
Reliant Processing, Ltd.Reliant Processing, Ltd. – FDA Inspection, Sep 11, 2015
Record Details
This FDA Inspection record concerns Reliant Processing, Ltd., with an inspection on September 11, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Reliant Processing, Ltd.
- Inspection Date
- September 11, 2015
- Product Type
- Drugs
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ID · dddaa50b-4527-43e9-80a5-0246fe6e2019
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941882
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Reliant Processing, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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