# FDA 483 - Ernest Jackson & Co., Ltd. - August 08, 2019

Source: https://www.keypedia.com/records/483/ernest-jackson-co-ltd/250b7e50-87f7-4c22-8268-ad455d4c749f

> FDA 483 for Ernest Jackson & Co., Ltd. on August 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ernest Jackson & Co., Ltd.
- Inspection Date: 2019-08-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This FDA Form 483 details significant deficiencies observed at Ernest Jackson & Co., Ltd. in Crediton, United Kingdom, during an inspection from August 5-8, 2019. The inspection revealed multiple issues related to quality control, equipment maintenance, temperature control, and adherence to written procedures, indicating a lack of robust manufacturing controls for drug products. Key concerns include the release of products without microbiological testing and inadequate cleaning validation.

## Related Documents

- [483 - 2022-10-21](https://www.keypedia.com/records/483/ernest-jackson-co-ltd/3ae2283e-536e-4cdc-802c-bf0b039d9e77)

## Related Officers

- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.keypedia.com/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

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