FDA Inspection 862323 — Michael A. Werner MD PC

Michael A. Werner MD PC — FEI 3008769595

The FDA completed an inspection of Michael A. Werner MD PC on Jan 24, 2014 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 24, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
New York, NY (United States)

Citations

IDCFRDescription
1249321 CFR 1271.90(c)Eligibility not required--warning labels