FDA Inspection
Lincare IncLincare Inc – FDA Inspection, Mar 25, 2015
Record Details
This FDA Inspection record concerns Lincare Inc, with an inspection on March 25, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lincare Inc
- Inspection Date
- March 25, 2015
- Product Type
- Drugs
View Company Profile
ID · 2b17c05a-d024-4e0d-86df-359e0148ec9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918936
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.198(b)Written complaint record to be maintained at facility
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Lincare Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lincare Inc
- FDA Inspection 719526 - 2011-04-12
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