FDA Inspection
BioCentric Labs IncFDA Inspection 628810 - BioCentric Labs Inc - November 13, 2009
Record Details
This FDA Inspection record concerns BioCentric Labs Inc, with an inspection on November 13, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BioCentric Labs Inc
- Inspection Date
- November 13, 2009
- Product Type
- Drugs
View Company Profile
ID · 964f0c7b-f5cc-44ec-aedd-efb710f92214
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 628810
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
18- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.165(a)Testing and release for distribution
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