FDA Inspection
Yusef Manufacturing Laboratories, LLCYusef Manufacturing Laboratories, LLC – FDA Inspection, May 26, 2016
Record Details
This FDA Inspection record concerns Yusef Manufacturing Laboratories, LLC, with an inspection on May 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 26, 2016
- Product Type
- Drugs
View Company Profile
ID · 1c2cb129-d3ce-4e4a-8b3f-7e90d349eade
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 984351
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
Showing 10 of 16 citations.
Full citation text and observation details available on the Dashboard.
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 |
| February 16, 2018 | Not classified | Denver District Office | Drug Quality Assurance |
| February 25, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Yusef Manufacturing Laboratories, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.