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

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.