FDA Inspection
Yusef Manufacturing Laboratories, LLCYusef Manufacturing Laboratories, LLC – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Yusef Manufacturing Laboratories, LLC, with an inspection on September 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a7f29eed-5e62-42ea-906c-ac1e0ec56f8f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1103172
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 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
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Other FDA inspections of Yusef Manufacturing Laboratories, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 24, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 16, 2018 | Not classified | Denver District Office | Drug Quality Assurance |
| May 26, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 25, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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