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First Warning Letter Issued Under DSCSA

FDA sends McKesson a warning, highlighting issues with illegitimate product notification, quarantining and record-keeping.

On Feb. 7, 2019, the FDA issued its first warning letter for verification requirements violations post-DSCSA enforcement date.

 

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 comes after a Form 483 was issued to the company back in July 2018. The FDA notes that the firm failed to respond to illegitimate product notifications as required, quarantine and investigate suspect product and keep records of the investigation of suspect product (for no less than 6 years).

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