FDA Inspection
Yusef Manufacturing Laboratories, LLCYusef Manufacturing Laboratories, LLC – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns Yusef Manufacturing Laboratories, LLC, with an inspection on February 16, 2018, issued by the Denver District Office, covering human drugs.
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ID · e39afc41-a39b-467a-bcad-0192cd2731b9
Inspection Facts
- Inspection number
- 1041369
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.188(b)(7)Documentation of Actual Yield and Theoretical Yield
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)GMP Training Frequency
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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 |
| September 13, 2019 | OAI | Center for Drug Evaluation and Research | 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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