FDA Inspection
Banner Pharmacy Services, LLCBanner Pharmacy Services, LLC – FDA Inspection, Sep 20, 2017
Record Details
This FDA Inspection record concerns Banner Pharmacy Services, LLC, with an inspection on September 20, 2017, issued by the Denver District Office, covering human drugs.
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ID · 23388b14-b32b-4725-93bc-1339966c0390
Inspection Facts
- Inspection number
- 1025990
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Banner Pharmacy Services, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2015 | OAI | Center for Drug Evaluation and Research | 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 919292 - 2015-03-20
- FDA Inspection 869432 - 2014-03-05
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