FDA Inspection
American Pharmacy of Illinois, Inc. dba Alwan Pharmacy and Compounding CenterAmerican Pharmacy of Illinois, Inc. dba Alwan Pharmacy and Compounding Center – FDA Inspection, Oct 28, 2015
Record Details
This FDA Inspection record concerns American Pharmacy of Illinois, Inc. dba Alwan Pharmacy and Compounding Center, with an inspection on October 28, 2015, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- October 28, 2015
- Product Type
- Veterinary
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ID · 6aef6866-6391-45f8-a31b-b858cb498c31
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 947435
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
16- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 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 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
Showing 10 of 16 citations.
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Other FDA inspections of American Pharmacy of Illinois, Inc. dba Alwan Pharmacy and Compounding Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for American Pharmacy of Illinois, Inc. dba Alwan Pharmacy and Compounding Center
- FDA Inspection 1062205 - 2018-07-17
- FDA Inspection 701624 - 2010-12-10
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