# FDA 483 - Enprani Co., Ltd. - March 11, 2019

Source: https://www.keypedia.com/records/483/enprani-co-ltd/5ebdcbc4-0f4f-40f5-af77-167b47864781

> FDA 483 for Enprani Co., Ltd. on March 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Enprani Co., Ltd.
- Inspection Date: 2019-03-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Enprani Co., Ltd., an OTC drug manufacturer in Incheon Jung, South Korea, revealed significant deficiencies across multiple areas of its operations. The firm was cited for inadequate laboratory records and controls, a lack of proper quality unit oversight, incomplete batch production records, and insufficient process validation. These observations indicate a failure to adhere to current good manufacturing practices, potentially impacting the quality and integrity of their drug products.

## Related Documents

- [WARNING_LETTER - 2019-03-15](https://www.keypedia.com/records/warning_letter/enprani-co-ltd/4836b60a-c407-4a7a-b07c-25e469ae2444)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.keypedia.com/companies/enprani-co-ltd/93d53494-d3cb-45f4-9eeb-8f545eeebb00

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1