FDA Inspection
Woodbine Products CompanyWoodbine Products Company – FDA Inspection, Sep 6, 2016
Record Details
This FDA Inspection record concerns Woodbine Products Company, with an inspection on September 6, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Woodbine Products Company
- Inspection Date
- September 6, 2016
- Product Type
- Drugs
View Company Profile
ID · fd85a7ba-c272-4184-817d-f4e3632e4afe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985003
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Woodbine Products Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | Not classified | Cincinnati District Office | Drug Quality Assurance |
| September 1, 2022 | 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 1303082 - 2026-02-13
- FDA Inspection 1179797 - 2022-09-01
- FDA Inspection 749084 - 2011-10-20
- FDA Inspection 636524 - 2009-12-16
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