FDA Inspection
Woodbine Products CompanyWoodbine Products Company – FDA Inspection, Feb 13, 2026
Record Details
This FDA Inspection record concerns Woodbine Products Company, with an inspection on February 13, 2026, issued by the Cincinnati District Office, covering human drugs.
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ID · a90c2669-1f13-4831-8c4d-75450030a688
Inspection Facts
- Inspection number
- 1303082
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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Other FDA inspections of Woodbine Products Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 20, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Woodbine Products Company
- FDA Inspection 1179797 - 2022-09-01
- FDA Inspection 985003 - 2016-09-06
- FDA Inspection 749084 - 2011-10-20
- FDA Inspection 636524 - 2009-12-16
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