FDA Inspection
CP Pharmaceuticals LimitedCP Pharmaceuticals Limited – FDA Inspection, Oct 13, 2015
Record Details
This FDA Inspection record concerns CP Pharmaceuticals Limited, with an inspection on October 13, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CP Pharmaceuticals Limited
- Inspection Date
- October 13, 2015
- Product Type
- Drugs
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ID · d9955946-83e0-447c-831e-ef2ec01361e0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 948044
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
Showing 10 of 12 citations.
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Other FDA inspections of CP Pharmaceuticals Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 13, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 29, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CP Pharmaceuticals Limited
- FDA Inspection 853032 - 2013-09-10
- FDA Inspection 724836 - 2011-05-13
- FDA Inspection 676852 - 2010-07-29
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