FDA Inspection
Showline Automotive Products, Inc. dba US Soaps Mfg. CompanyShowline Automotive Products, Inc. dba US Soaps Mfg. Company – FDA Inspection, Sep 24, 2009
Record Details
This FDA Inspection record concerns Showline Automotive Products, Inc. dba US Soaps Mfg. Company, with an inspection on September 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 24, 2009
- Product Type
- Drugs
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ID · 0a1f82d2-1c1b-40e7-8d90-071907d8a3fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615791
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.186(b)(4)Variation in the Amount of Components Used
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
Showing 10 of 14 citations.
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Other FDA inspections of Showline Automotive Products, Inc. dba US Soaps Mfg. Company
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Showline Automotive Products, Inc. dba US Soaps Mfg. Company
- FDA Inspection 841542 - 2013-07-22
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