FDA Inspection
ProFresh International Corp.ProFresh International Corp. – FDA Inspection, Jan 10, 2020
Record Details
This FDA Inspection record concerns ProFresh International Corp., with an inspection on January 10, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ProFresh International Corp.
- Inspection Date
- January 10, 2020
- Product Type
- Drugs
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ID · c149543b-5e9c-49ca-9758-fd478023ce6a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1114778
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.166(a)Lack of written stability program
- 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 |
|---|---|---|---|
| July 16, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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