FDA Inspection
Yusef Manufacturing Laboratories, LLCYusef Manufacturing Laboratories, LLC – FDA Inspection, Nov 4, 2022
Record Details
This FDA Inspection record concerns Yusef Manufacturing Laboratories, LLC, with an inspection on November 4, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 4, 2022
- Product Type
- Drugs
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ID · 4329da34-d1c9-441c-a789-134f3d3a965a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1187498
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.84(b)Representative Samples Criteria
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Yusef Manufacturing Laboratories, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2021 | 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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