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."
Read the FDA warning letter: McKesson Corporation Headquarters 2/7/19 - FDA Warning Letter
Return Home: The Designated Representative and Exemptee Blog
--------------
California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - courses for wholesalers, 3PL, reverse distributors |
For Designated Representative license applicants - Training programs, courses, classes, seminars:
California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
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
ReplyDeleteWho Are You Going To Call? These Collaboration Partners (for all things pharma & drug distribution related).
ReplyDelete