# FDA 483 - MW Encap Ltd.(NextPharma Edinburgh) - December 14, 2018

Source: https://www.keypedia.com/records/483/mw-encap-ltdnextpharma-edinburgh/2f8de399-d089-4991-bc21-4bc27110ad5f

> FDA 483 for MW Encap Ltd.(NextPharma Edinburgh) on December 14, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MW Encap Ltd.(NextPharma Edinburgh)
- Inspection Date: 2018-12-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mw Encap Ltd. in Livingston, United Kingdom, was inspected and cited for significant deficiencies in its quality control laboratory. The inspection revealed inadequate controls over computerized systems, leading to concerns about data integrity, unauthorized data manipulation, and lack of proper data backup. Additionally, the firm failed to conduct necessary investigations for errors, retests, and out-of-specification results, further compromising the reliability of its electronic records.

## Related Officers

- [Mesfin Abdi](https://www.keypedia.com/people/mesfin-abdi/22e86ff6-6066-48e0-b333-ac2de66214f7)
- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

Company: https://www.keypedia.com/companies/mw-encap-ltdnextpharma-edinburgh/e8cf1af5-d17a-4c79-ba7d-498a371fbc50

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