# FDA 483 - Englewood Lab Korea Co., Ltd. - October 25, 2024

Source: https://www.keypedia.com/records/483/englewood-lab-korea-co-ltd/6a134621-bb4b-4ce8-82d1-ddff864c603a

> FDA 483 for Englewood Lab Korea Co., Ltd. on October 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Englewood Lab Korea Co., Ltd.
- Inspection Date: 2024-10-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Englewood Lab Korea Co., Ltd., an OTC pharmaceutical manufacturer, revealed three significant observations. These included deficiencies in microbiological testing of components, failure to fully follow quality control unit procedures, and inadequate recording and justification of deviations from production and process control procedures, specifically regarding actions to prevent reoccurrence.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/englewood-lab-korea-co-ltd/124fc09e-6782-4d8d-b398-79ac995f85b8

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8