FDA Inspection
Laboratoria Qualiphar NVLaboratoria Qualiphar NV – FDA Inspection, May 7, 2010
Record Details
This FDA Inspection record concerns Laboratoria Qualiphar NV, with an inspection on May 7, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratoria Qualiphar NV
- Inspection Date
- May 7, 2010
- Product Type
- Drugs
View Company Profile
ID · 98f3ae7f-26d8-482a-ba0e-d7771eee703f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 664164
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188(b)(10)Records of any sampling performed
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.184(e)Records of disposition of rejected material
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.182Dedicated equipment: records part of batch record
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.110(a)Written in-process control procedures
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