FDA Inspection
Jabones Y Productos Especializados SA de CVJabones Y Productos Especializados SA de CV – FDA Inspection, Mar 23, 2018
Record Details
This FDA Inspection record concerns Jabones Y Productos Especializados SA de CV, with an inspection on March 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5cd197a5-ffa1-4820-9260-831ec947dd7e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1045390
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 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 211.80(d)Identification of Each Lot in Each Shipment
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.67(b)Written procedures fail to include
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