FDA Inspection
Medicia Holdings LLCMedicia Holdings LLC – FDA Inspection, Nov 4, 2011
Record Details
This FDA Inspection record concerns Medicia Holdings LLC, with an inspection on November 4, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Medicia Holdings LLC
- Inspection Date
- November 4, 2011
- Product Type
- Drugs
View Company Profile
ID · c78619de-f9dc-47d5-913d-fdef8caad579
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 751414
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Medicia Holdings LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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