FDA Inspection
Spencer Specialty Products IncSpencer Specialty Products Inc – FDA Inspection, Apr 4, 2025
Record Details
This FDA Inspection record concerns Spencer Specialty Products Inc, with an inspection on April 4, 2025, issued by the Seattle District Office, covering human drugs.
- Office
- Seattle District Office
- Person
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ID · caeeddf4-0a78-44d8-85ce-df0337c225a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1265908
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Spencer Specialty Products Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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