FDA Inspection
NuGeneration Technologies, LLCNuGeneration Technologies, LLC – FDA Inspection, Sep 22, 2022
Record Details
This FDA Inspection record concerns NuGeneration Technologies, LLC, with an inspection on September 22, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 22, 2022
- Product Type
- Drugs
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ID · b5c86f6c-ce61-4b53-88c2-a0a712ff26ef
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1180241
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.100(a)Absence of Written Procedures
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