FDA Inspection 813486 — RMC Orthopedic & Surgical, Inc.
The FDA completed an inspection of RMC Orthopedic & Surgical, Inc. on December 31, 2012 in Guaynabo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 31, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Guaynabo, PR (United States)