FDA Inspection
Cyndea PharmaCyndea Pharma – FDA Inspection, Apr 12, 2019
Record Details
This FDA Inspection record concerns Cyndea Pharma, with an inspection on April 12, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 73f5294d-8899-4e20-a970-aff6ed952a8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086283
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Cyndea Pharma
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 3, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 13, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Cyndea Pharma
- FDA Inspection 1276972 - 2022-03-10
- FDA Inspection 1134755 - 2019-04-03
- FDA Inspection 1004186 - 2017-01-13
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