MedPharm, LLC – FDA Warning Letter, May 6, 2009
On December 20, 2011, the FDA issued a Warning Letter to MedPharm, LLC, citing violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to Import for Export (IFE) provisions. The letter states that MedPharm failed to provide requested records and a report concerning drug components imported under entry number N90-0842717-7.
Specifically, MedPharm violated Sections 801(d)(3)(A)(iv), 801(d)(3)(A)(v), and 301(w) of the FD&C Act by failing to provide records on the use or destruction of imported drugs and a report accounting for their exportation or destruction upon FDA's request. The FDA sent a request letter on October 18, 2011, requiring a response within 14 working days, which MedPharm did not provide.
The letter also notes that MedPharm's intermediate shipper, Resolution, Inc., also failed to provide requested information for the same import entry following FDA requests in May and July 2011. Concerns were also raised regarding MedPharm's compliance with the requirement to export or destroy IFE drug components, based on a February and May 2009 inspection of Resolution Inc.'s facility.
MedPharm is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A
- Company
- MedPharm, LLC
- Inspection date
- May 6, 2009
ID · 80fdc6ed-d85b-4b8b-9421-8c1ea3df6ed0
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