FDA Inspection
North Pine Enterprises, Inc.North Pine Enterprises, Inc. – FDA Inspection, Aug 11, 2011
Record Details
This FDA Inspection record concerns North Pine Enterprises, Inc., with an inspection on August 11, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- North Pine Enterprises, Inc.
- Inspection Date
- August 11, 2011
- Product Type
- Drugs
View Company Profile
ID · fdb9d07c-b14b-4ae6-b6b7-e383db857963
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 740654
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of North Pine Enterprises, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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