FDA Inspection
Urvesh Psyllium Industries Ltd.Urvesh Psyllium Industries Ltd. – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Urvesh Psyllium Industries Ltd., with an inspection on February 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 80d17319-2795-4467-a002-1b2dd3792b9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042148
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.180(b)Record maintenance 3 years (exempt OTC drugs)
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.52Washing and toilet facilities are deficient
- 21 CFR 211.67(b)Written procedures not established/followed
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