# FDA 483 - Nowcos Co., Ltd - September 06, 2019

Source: https://www.globalkeysolutions.net/records/483/nowcos-co-ltd/b8f67fb5-3ec7-410a-aef0-100790fa7764

> FDA 483 for Nowcos Co., Ltd on September 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nowcos Co., Ltd
- Inspection Date: 2019-09-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Nowcos Co., Ltd, an OTC drug manufacturer in Sejeong-myeon, Sejeong-si, Korea, was cited for ten significant deficiencies during an FDA inspection from September 2-6, 2019. The observations primarily concern inadequate computer system controls, deficient test method validation, lack of cleaning and process validations, and insufficient laboratory controls and record-keeping. Many of these issues were repeat observations from a previous 2017 inspection, indicating persistent non-compliance with GMP regulations.

## Related Documents

- [483 - 2017-08-04](https://www.globalkeysolutions.net/records/483/nowcos-co-ltd/83d47884-7742-41b2-bfcd-b86ee2093ab7)
- [WARNING_LETTER - 2017-08-04](https://www.globalkeysolutions.net/records/warning_letter/nowcos-co-ltd/55ae4693-ef78-4ff9-bbed-6d39fe72792c)
- [EIR - 2019-09-06](https://www.globalkeysolutions.net/records/eir/nowcos-co-ltd/53e7641e-e39b-45dd-b3bf-ca2d498c2a96)

## Related Officers

- [Christopher S. Keating](https://www.globalkeysolutions.net/people/christopher-s-keating/94fcfd32-feb5-4b6c-80da-16202f4be01d)

Company: https://www.globalkeysolutions.net/companies/nowcos-co-ltd/93e00398-0c40-483b-a6bd-e877fa95eae3

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