FDA Inspection
Lincare, Inc. dba Alert MedicalLincare, Inc. dba Alert Medical – FDA Inspection, May 5, 2011
Record Details
This FDA Inspection record concerns Lincare, Inc. dba Alert Medical, with an inspection on May 5, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 5, 2011
- Product Type
- Drugs
View Company Profile
ID · e7c184de-1128-4609-a143-2e35dba9085c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 723129
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.150(a)Distribution of oldest stock first
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.204Returned drug products identified and held
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.142(a)Quarantine - written procedures
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lincare, Inc. dba Alert Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lincare, Inc. dba Alert Medical
- FDA Inspection 785325 - 2012-06-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.