FDA Inspection
First Time US Generics LLCFirst Time US Generics LLC – FDA Inspection, Feb 15, 2018
Record Details
This FDA Inspection record concerns First Time US Generics LLC, with an inspection on February 15, 2018, issued by the Philadelphia District Office, covering human drugs.
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ID · 2c67912a-7644-49c7-8eb4-bc6863d83e5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041114
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of First Time US Generics LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 8, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for First Time US Generics LLC
- FDA Inspection 1226951 - 2024-01-12
- FDA Inspection 1024876 - 2017-06-08
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