FDA Inspection
Nuline Pharmaceuticals, Inc.Nuline Pharmaceuticals, Inc. – FDA Inspection, Apr 27, 2011
Record Details
This FDA Inspection record concerns Nuline Pharmaceuticals, Inc., with an inspection on April 27, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Nuline Pharmaceuticals, Inc.
- Inspection Date
- April 27, 2011
- Product Type
- Drugs
View Company Profile
ID · 8aecedfe-884e-4936-8a18-a0751966e5df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 721644
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.125(d)Destruction of excess labels with lot numbers
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Nuline Pharmaceuticals, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Nuline Pharmaceuticals, Inc.
- FDA Inspection 752011 - 2011-10-14
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