FDA Inspection
S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITEDS & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED – FDA Inspection, Jul 21, 2023
Record Details
This FDA Inspection record concerns S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED, with an inspection on July 21, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 21, 2023
- Product Type
- Drugs
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ID · 5096baa7-5f38-420b-bb9c-36b25af83579
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1210508
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
6- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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