FDA Inspection
SPF Consulting Labs, Inc.SPF Consulting Labs, Inc. – FDA Inspection, May 20, 2011
Record Details
This FDA Inspection record concerns SPF Consulting Labs, Inc., with an inspection on May 20, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SPF Consulting Labs, Inc.
- Inspection Date
- May 20, 2011
- Product Type
- Drugs
View Company Profile
ID · 647b0357-f4f0-4170-ba56-da974453c0dd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 725660
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.184(c)Individual inventory record
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