Wednesday, February 13, 2019

FDA Issues Warning Letter To McKesson For DSCSA Violations

Read the full article:  First Warning Letter Issued Under DSCSA - FDA sends McKesson a warning, highlighting issues with illegitimate product notification, quarantining and record-keeping - Healthcare Packaging

"According to the letter to McKesson, “The verification requirements at issue include those that apply to wholesale distributors when they determine or are notified that a product is suspect or illegitimate.”  . . . 
The letter highlights two other examples in which the firm did not demonstrate proper quarantining of suspect product or provide records to show that requirements were met in identifying illegitimate product or subsequent requirements."

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2 comments:

  1. You might also be interested in NABP Drug Distributor Accreditation (formerly VAWD). GTC Consulting provides consulting for all things related to pharmaceutical controlled substances and quality accreditations: GTC Consulting

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