FDA Inspection
Pro-Blending LLCPro-Blending LLC – FDA Inspection, Feb 5, 2020
Record Details
This FDA Inspection record concerns Pro-Blending LLC, with an inspection on February 5, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pro-Blending LLC
- Inspection Date
- February 5, 2020
- Product Type
- Drugs
View Company Profile
ID · 92486af3-4cf4-4912-8d9d-47baf4752fa6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1116922
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
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Other FDA inspections of Pro-Blending LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2015 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Pro-Blending LLC
- FDA Inspection 943604 - 2015-09-24
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