FDA Inspection
Creative Pharmacy Solutions Central LLC dba Pharmacy InnovationsCreative Pharmacy Solutions Central LLC dba Pharmacy Innovations – FDA Inspection, Aug 1, 2016
Record Details
This FDA Inspection record concerns Creative Pharmacy Solutions Central LLC dba Pharmacy Innovations, with an inspection on August 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 1, 2016
- Product Type
- Drugs
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ID · 483030b2-c3ee-481e-a168-8f0c82612ea3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 982348
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.100(a)Absence of Written Procedures
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