Newsletter - April 22, 2021
Emergent’s FDA Audit Indicates Poor Vendor Validation by J & J
Yesterday FDA published the FDA 483 for Emergent’s vaccine manufacturing facility in Baltimore listing a litany of non-compliance findings made by its inspectors, and it points to the abysmal job done by J&J’s vendor validation team. Prior to giving a contract to a vendor...Read More
FDA To Limit Interstate Distribution of Compounded Drugs
Compounding pharmacies will be limited to distributing less than 5% of their compounded drugs out of the state in which they are physically located starting 27 October 2021. Many compounding pharmacies ship more than 50% of their compounded drugs out of state meaning these pharmacies...Read More
Emergent’s FDA Audit Indicates Poor Vendor Validation by J & J
Yesterday FDA published the FDA 483 for Emergent’s vaccine manufacturing facility in Baltimore listing a litany of non-compliance findings made by its inspectors, and it points to the abysmal job done by J&J’s vendor validation team. Prior to giving a contract to a vendor...Read More
FDA To Limit Interstate Distribution of Compounded Drugs
Compounding pharmacies will be limited to distributing less than 5% of their compounded drugs out of the state in which they are physically located starting 27 October 2021. Many compounding pharmacies ship more than 50% of their compounded drugs out of state meaning these pharmacies...Read More
