# Epien Medical, Inc – FDA Inspection, Dec 6, 2018

Source: https://www.keypedia.com/records/fda_inspections/epien-medical-inc/55a34371-4635-46b4-ac71-b1bfcad72040
Source feed: FDA_Inspections

> FDA inspection 1073560 of Epien Medical, Inc, December 06, 2018. Classification: Voluntary Action Indicated (VAI). 3 citations under 21 CFR part 211. Form 483 issued. 6 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1073560
- Company Name: Epien Medical, Inc
- Inspection Date: 2018-12-06
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Drug Quality Assurance
- Product Type: Drugs
- Center: Human Drugs
- Office Name: Center for Drug Evaluation and Research
- Citation Count: 3

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## Related Officers

- [FDA Associated Person](https://www.keypedia.com/people/james-k-ireland/78658286-3e62-4069-a8e1-b157aa77c7fe)

Company: https://www.keypedia.com/companies/epien-medical-inc/448146b7-762c-4524-a71f-3308726efffd

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c