FDA Inspection
Revitol CorporationRevitol Corporation – FDA Inspection, Jun 1, 2012
Record Details
This FDA Inspection record concerns Revitol Corporation, with an inspection on June 1, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Revitol Corporation
- Inspection Date
- June 1, 2012
- Product Type
- Drugs
View Company Profile
ID · 866a9dd5-06b0-46d2-9fa7-ea6ec83a576f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781688
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 111.140(b)(1)Records - quality control operations; responsibilities
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
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