FDA Inspection
College Pharmacy, Inc.College Pharmacy, Inc. – FDA Inspection, May 28, 2015
Record Details
This FDA Inspection record concerns College Pharmacy, Inc., with an inspection on May 28, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- College Pharmacy, Inc.
- Inspection Date
- May 28, 2015
- Product Type
- Drugs
View Company Profile
ID · a048b310-6289-442d-9063-aa2146c4d124
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 926643
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.166(a)(3)Valid stability test methods
Full citation text and observation details available on the Dashboard.
Other FDA inspections of College Pharmacy, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 17, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2013 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for College Pharmacy, Inc.
- FDA Inspection 1158430 - 2021-11-15
- FDA Inspection 1038075 - 2018-01-17
- FDA Inspection 823528 - 2013-03-15
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