FDA Inspection
Owen Biosciences Inc.Owen Biosciences Inc. – FDA Inspection, May 15, 2026
Record Details
This FDA Inspection record concerns Owen Biosciences Inc., with an inspection on May 15, 2026, issued by the New Orleans District Office, covering human drugs.
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ID · 1491cab9-5f76-4144-81b7-160d8aa35d82
Inspection Facts
- Inspection number
- 1320972
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Owen Biosciences Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2025 | OAI | New Orleans District Office | Drug Quality Assurance |
| February 14, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 19, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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