FDA Inspection
Showline Automotive Products IncorporatedShowline Automotive Products Incorporated – FDA Inspection, Jul 9, 2010
Record Details
This FDA Inspection record concerns Showline Automotive Products Incorporated, with an inspection on July 9, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 9, 2010
- Product Type
- Drugs
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ID · e8581cb7-8b97-4f1a-90d1-ed9022f50ad1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 673530
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.115(a)Reprocessing procedures lack steps to be taken
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Other FDA inspections of Showline Automotive Products Incorporated
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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