FDA Inspection
Banner Pharmacy Services, LLCBanner Pharmacy Services, LLC – FDA Inspection, Mar 20, 2015
Record Details
This FDA Inspection record concerns Banner Pharmacy Services, LLC, with an inspection on March 20, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 20, 2015
- Product Type
- Drugs
View Company Profile
ID · 00586011-3758-47fc-9a06-b20091bb0f14
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 919292
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(c)(7)Quarantined Drug Products Area
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Banner Pharmacy Services, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2017 | Not classified | Denver District Office | Drug Quality Assurance |
| March 5, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Banner Pharmacy Services, LLC
- FDA Inspection 1025990 - 2017-09-20
- FDA Inspection 869432 - 2014-03-05
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.