FDA Inspection
Dr. Frank's Health Products LLCDr. Frank's Health Products LLC – FDA Inspection, Aug 11, 2010
Record Details
This FDA Inspection record concerns Dr. Frank's Health Products LLC, with an inspection on August 11, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 11, 2010
- Product Type
- Drugs
View Company Profile
ID · aefa599c-8f2e-490a-8161-0b2597a55f6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672836
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.198(b)(1)Complaint Record required information
- 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
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.