FDA Inspection
LincareLincare – FDA Inspection, Feb 24, 2010
Record Details
This FDA Inspection record concerns Lincare, with an inspection on February 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lincare
- Inspection Date
- February 24, 2010
- Product Type
- Drugs
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ID · ffa94db3-43e9-4fdf-8e5a-4a60964b7af6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 648127
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
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