FDA Inspection
Keeler's Medical Supply, IncKeeler's Medical Supply, Inc – FDA Inspection, Jun 26, 2015
Record Details
This FDA Inspection record concerns Keeler's Medical Supply, Inc, with an inspection on June 26, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Keeler's Medical Supply, Inc
- Inspection Date
- June 26, 2015
- Product Type
- Drugs
View Company Profile
ID · 190b6bae-1181-4679-9173-70d7b894967d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 932781
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188(a)Accurate reproduction included
- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Keeler's Medical Supply, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Keeler's Medical Supply, Inc
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.