FDA Inspection
ProFresh International Corp.ProFresh International Corp. – FDA Inspection, Jul 16, 2021
Record Details
This FDA Inspection record concerns ProFresh International Corp., with an inspection on July 16, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ProFresh International Corp.
- Inspection Date
- July 16, 2021
- Product Type
- Drugs
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ID · 240dafbe-ee2f-465c-8263-4e72cb796b21
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1147163
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of ProFresh International Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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