FDA Inspection
Summerton Drug Compounding and DispensarySummerton Drug Compounding and Dispensary – FDA Inspection, Oct 17, 2014
Record Details
This FDA Inspection record concerns Summerton Drug Compounding and Dispensary, with an inspection on October 17, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 17, 2014
- Product Type
- Drugs
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ID · 141f44c1-8129-4795-a174-e029b9e43069
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940216
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- State Referral Letter
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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