FDA Inspection
Poon Goor Soe Manufacture Sdn BhdPoon Goor Soe Manufacture Sdn Bhd – FDA Inspection, Jul 26, 2019
Record Details
This FDA Inspection record concerns Poon Goor Soe Manufacture Sdn Bhd, with an inspection on July 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · afc646b2-8b76-4ac7-9c28-47ec915255a3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1097510
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures fail to include
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