FDA Inspection
Showline Automotive Products IncorporatedShowline Automotive Products Incorporated – FDA Inspection, Nov 8, 2012
Record Details
This FDA Inspection record concerns Showline Automotive Products Incorporated, with an inspection on November 8, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 8, 2012
- Product Type
- Drugs
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ID · 0bb6fdfa-0cb6-4cc9-93e3-48522364cdbd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 805616
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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Other FDA inspections of Showline Automotive Products Incorporated
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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