FDA Inspection
Lincare IncLincare Inc – FDA Inspection, Apr 8, 2009
Record Details
This FDA Inspection record concerns Lincare Inc, with an inspection on April 8, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lincare Inc
- Inspection Date
- April 8, 2009
- Product Type
- Drugs
View Company Profile
ID · 4477148a-d1ab-4a8b-a243-30ccfdee67cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579709
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
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Other FDA inspections of Lincare Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 25, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 6, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 17, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lincare Inc
- FDA Inspection 883931 - 2014-06-19
- FDA Inspection 876165 - 2014-04-25
- FDA Inspection 777512 - 2012-04-20
- FDA Inspection 765323 - 2012-02-06
- FDA Inspection 648371 - 2010-02-17
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