FDA Inspection
JSA International Inc.JSA International Inc. – FDA Inspection, Oct 30, 2012
Record Details
This FDA Inspection record concerns JSA International Inc., with an inspection on October 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- JSA International Inc.
- Inspection Date
- October 30, 2012
- Product Type
- Drugs
View Company Profile
ID · 68da8404-9ee3-417a-a508-64d0c63c4e19
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 806845
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
14- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.403Written procedures -packaging operations
- 21 CFR 111.103Written procedure quality control operations material review
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.510Returned dietary supplement - material review, disposition
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
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