FDA Inspection
Lincare IncorporatedLincare Incorporated – FDA Inspection, Jan 27, 2010
Record Details
This FDA Inspection record concerns Lincare Incorporated, with an inspection on January 27, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lincare Incorporated
- Inspection Date
- January 27, 2010
- Product Type
- Drugs
View Company Profile
ID · 0d9a96a3-f7cd-4e72-84fc-535b1747502d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 641477
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188(a)Accurate reproduction included
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Lincare Incorporated
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 10, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lincare Incorporated
- FDA Inspection 756040 - 2011-12-07
- FDA Inspection 650999 - 2010-03-10
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