Showing posts with label warning letter. Show all posts
Showing posts with label warning letter. Show all posts

Monday, September 14, 2020

Manufacturing FDA ticks off list of grievances over California drug repackager's quality issues in warning letter - FiercePharma

This should interest wholesalers specializing or involved in drug repackaging.

According to the article:

"Unlike drugmakers that make their meds in-house, a cottage industry of repackagers exists to resell premade drugs with shiny new labels. But what happens when one of those companies fails at its primary job: safely repackaging drugs? A California firm has just found out, courtesy of the FDA. 

Newport Beach, California-based Calvin Scott & Co., a wholesaler specializing in drug repackaging, failed to adequately address quality issues at its New Mexico plant that may have compromised the listed expiration date on one of its drugs, according to a warning letter posted online this week."

Read the full source article:  Manufacturing FDA ticks off list of grievances over California drug repackager's quality issues in warning letter - FiercePharma

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Wednesday, February 13, 2019

FDA Issues Warning Letter To McKesson For DSCSA Violations

Updated June 20, 2025

The original link to the article broke.

---  the original post follows below  ---

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."


Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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