FDA Inspection
Dr. Frank's Pain Spray, LLCDr. Frank's Pain Spray, LLC – FDA Inspection, Aug 11, 2010
Record Details
This FDA Inspection record concerns Dr. Frank's Pain Spray, LLC, with an inspection on August 11, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Dr. Frank's Pain Spray, LLC
- Inspection Date
- August 11, 2010
- Product Type
- Drugs
View Company Profile
ID · 653ed903-37fc-49c4-88be-8051ab8b813c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676255
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
- 21 CFR 211.198(b)(1)Complaint Record required information
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.204Record information inclusions
- Failure of responsible person to report AE (non-RX Drug)
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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