FDA Inspection
Deep Freeze, LLCDeep Freeze, LLC – FDA Inspection, Apr 28, 2011
Record Details
This FDA Inspection record concerns Deep Freeze, LLC, with an inspection on April 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Deep Freeze, LLC
- Inspection Date
- April 28, 2011
- Product Type
- Drugs
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ID · e00dbeb1-402b-4789-9c9e-6d6b72b32580
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 719483
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.160(b)(2)In process materials - conformance to written specs
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Deep Freeze, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2017 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 28, 2012 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 22, 2010 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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