FDA Inspection
Spencer Specialty Products IncSpencer Specialty Products Inc – FDA Inspection, Apr 25, 2019
Record Details
This FDA Inspection record concerns Spencer Specialty Products Inc, with an inspection on April 25, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 255c72e8-72d2-426a-ad81-9017b9f2a851
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087396
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.137(d)Expiration date location on labeling
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.42(c)(9)Control / Lab Operations Area
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Spencer Specialty Products Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2025 | VAI | Seattle District Office | Drug Quality Assurance |
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