FDA Inspection
Knoll Medical, LLCKnoll Medical, LLC – FDA Inspection, May 26, 2011
Record Details
This FDA Inspection record concerns Knoll Medical, LLC, with an inspection on May 26, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Knoll Medical, LLC
- Inspection Date
- May 26, 2011
- Product Type
- Drugs
View Company Profile
ID · 7722cde4-edd7-47da-b7c1-f6da36984390
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 725102
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Knoll Medical, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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