# FDA 483 - Ernest Jackson & Co., Ltd. - October 21, 2022

Source: https://www.keypedia.com/records/483/ernest-jackson-co-ltd/3ae2283e-536e-4cdc-802c-bf0b039d9e77

> FDA 483 for Ernest Jackson & Co., Ltd. on October 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ernest Jackson & Co., Ltd.
- Inspection Date: 2022-10-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Ernest Jackson & Co., Ltd. in Crediton, UK, revealed significant deficiencies in their manufacturing operations. The firm failed to establish adequate production and process controls, particularly concerning equipment cleaning, cross-contamination prevention, and batch segregation. Additionally, the inspection found failures in investigating discrepancies and customer complaints, and a lack of proper verification for microbiology testing results.

## Related Documents

- [483 - 2019-08-08](https://www.keypedia.com/records/483/ernest-jackson-co-ltd/250b7e50-87f7-4c22-8268-ad455d4c749f)

## Related Officers

- [Sena G. Dissmeyer](https://www.keypedia.com/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)

Company: https://www.keypedia.com/companies/ernest-jackson-co-ltd/eb52a55e-1aac-4858-952a-d59696312ee9

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