FDA Slams the Door on New Jersey Company

FDA issued an Order to Cease Manufacturing to BioMedical Tissue Services Ltd. last week. Read this six page letter outlining their violations. Note they define "manufacturing" to mean any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cells, tissues, and cellular and tissue-based products (HCT/Ps), and the screening or testing of the HCT/P donor.

Find this letter at http://www.gmptrainingsystems.com/asp/resources.asp
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Use this article in your GMP training to point out the consequences of non-compliance.

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