FDA Inspection
Thomas E. Young, MD, LLCThomas E. Young, MD, LLC – FDA Inspection, Jan 12, 2012
Record Details
This FDA Inspection record concerns Thomas E. Young, MD, LLC, with an inspection on January 12, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Thomas E. Young, MD, LLC
- Inspection Date
- January 12, 2012
- Product Type
- Biologics
View Company Profile
ID · 6650ad19-429f-43f8-9d8f-11a56c8d9e6a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 759300
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
14- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.80(d)Disposition recorded by lot identification
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