FDA Inspection
Unico Research Laboratory Inc. dba Spencer Lab. Int'l.Unico Research Laboratory Inc. dba Spencer Lab. Int'l. – FDA Inspection, Jun 29, 2011
Record Details
This FDA Inspection record concerns Unico Research Laboratory Inc. dba Spencer Lab. Int'l., with an inspection on June 29, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 29, 2011
- Product Type
- Drugs
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ID · c570e061-1b8b-4c65-9cd1-b83ff6e6186a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 732515
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Unico Research Laboratory Inc. dba Spencer Lab. Int'l.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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