FDA Inspection
North Pine Enterprises, Inc.North Pine Enterprises, Inc. – FDA Inspection, Nov 20, 2013
Record Details
This FDA Inspection record concerns North Pine Enterprises, Inc., with an inspection on November 20, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- North Pine Enterprises, Inc.
- Inspection Date
- November 20, 2013
- Product Type
- Drugs
View Company Profile
ID · fda18ec4-56f8-4de6-8a95-b0bffda73ce7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857859
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of North Pine Enterprises, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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