FDA 483 - Ernest Jackson & Co., Ltd. - August 08, 2019
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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.
ID · 250b7e50-87f7-4c22-8268-ad455d4c749f