FDA Inspection
CPC Acquisition, Inc.CPC Acquisition, Inc. – FDA Inspection, Feb 11, 2009
Record Details
This FDA Inspection record concerns CPC Acquisition, Inc., with an inspection on February 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CPC Acquisition, Inc.
- Inspection Date
- February 11, 2009
- Product Type
- Drugs
View Company Profile
ID · 173017be-fa4e-44d5-8e56-95cc92fd0874
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 557796
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
24- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.101(c)Weighing/measuring/subdividing supervision
- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.101(d)Component release checked by 2nd person
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
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