FDA Inspection
Johnson Labs IncJohnson Labs Inc – FDA Inspection, Apr 23, 2009
Record Details
This FDA Inspection record concerns Johnson Labs Inc, with an inspection on April 23, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Johnson Labs Inc
- Inspection Date
- April 23, 2009
- Product Type
- Drugs
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ID · fe24785c-3b8f-4043-9496-4cc80bc48bff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579181
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Lack of quality control unit
Showing 10 of 11 citations.
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Other FDA inspections of Johnson Labs Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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