FDA Inspection
Yusef Manufacturing Laboratories, LLCYusef Manufacturing Laboratories, LLC – FDA Inspection, Sep 24, 2021
Record Details
This FDA Inspection record concerns Yusef Manufacturing Laboratories, LLC, with an inspection on September 24, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 24, 2021
- Product Type
- Drugs
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ID · 110b3540-7f35-4904-9f45-64909df93e4c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1152591
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
30- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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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 13, 2019 | 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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