FDA Inspection
Buderer Drug Company IncBuderer Drug Company Inc – FDA Inspection, Jan 4, 2016
Record Details
This FDA Inspection record concerns Buderer Drug Company Inc, with an inspection on January 4, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Buderer Drug Company Inc
- Inspection Date
- January 4, 2016
- Product Type
- Drugs
View Company Profile
ID · 8964d446-a5b2-4b1f-aeea-6e1464b1b663
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 959244
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Buderer Drug Company Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2017 | Not classified | Cincinnati District Office |
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