FDA Inspection
Diabetes Corporation of AmericaDiabetes Corporation of America – FDA Inspection, Aug 20, 2015
Record Details
This FDA Inspection record concerns Diabetes Corporation of America, with an inspection on August 20, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 20, 2015
- Product Type
- Drugs
View Company Profile
ID · 307a0f9f-8347-46ca-bddf-21c4c5d5d069
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 939265
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 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 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.111Establishment of time limitations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Diabetes Corporation of America
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Diabetes Corporation of America
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.