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, Jul 17, 2018
Record Details
This FDA Inspection record concerns American Pharmacy of Illinois, Inc. dba Alwan Pharmacy and Compounding Center, with an inspection on July 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 17, 2018
- Product Type
- Drugs
View Company Profile
ID · 3f207d0a-9be2-40a2-8dd2-29f35d7dd2ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062205
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
- FDCA 501(a)(2)(A)Non-sterilized and non-depyrogenated, sterile drug
- FDCA 501(a)(2)(A)Highly potent drugs, prevention of cross-contamination
- FDCA 501(a)(2)(A)Air flow quality, higher classified area
- FDCA 501(a)(2)(A)Use of non-pharmaceutical grade components
- FDCA 501(a)(2)(A)Air flow quality, higher classified area
- FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
- FDCA 501(a)(2)(A)Highly potent drugs, prevention of cross-contamination
- FDCA 501(a)(2)(A)Non-sterilized and non-depyrogenated, sterile drug
- FDCA 501(a)(2)(A)Use of non-pharmaceutical grade components
Full citation text and observation details available on the Dashboard.
Other FDA inspections of American Pharmacy of Illinois, Inc. dba Alwan Pharmacy and Compounding Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2015 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| 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 947435 - 2015-10-28
- FDA Inspection 701624 - 2010-12-10
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.