FDA Inspection
Jaychem Industries LtdJaychem Industries Ltd – FDA Inspection, Jul 10, 2014
Record Details
This FDA Inspection record concerns Jaychem Industries Ltd, with an inspection on July 10, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Jaychem Industries Ltd
- Inspection Date
- July 10, 2014
- Product Type
- Drugs
View Company Profile
ID · 7cbf9eea-73eb-4868-b271-61898eba1f0b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 890008
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Written in-process control procedures
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