FDA Inspection
Lincare IncLincare Inc – FDA Inspection, Apr 12, 2010
Record Details
This FDA Inspection record concerns Lincare Inc, with an inspection on April 12, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lincare Inc
- Inspection Date
- April 12, 2010
- Product Type
- Drugs
View Company Profile
ID · a3ccc864-8bfa-4986-a481-2923bc83690f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 656974
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.198(b)Written complaint record to be maintained at facility
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192No written record of investigation
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