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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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MedPharm, LLC 12/20/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX:   (615) 366-7802

 

December 20, 2011
 
WARNING LETTER No 2012-NOL-06
 
 
United Parcel Service
Delivery Signature Requested
 
Mr. Andrew Koval, President
MedPharm, LLC
1101 King Street, Suite 360
Alexandria, Virginia 22314
 
Dear Mr. Koval:
 
This letter concerns MedPharm LLC’s (MedPharm’s) failure to provide Import for Export records and a report upon request to the Food and Drug Administration (FDA) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) [21 U.S.C. § 301 et seq.]. 
 
On September 16, 2008, you notified FDA of your intent to import drugs in entry number N90-0842717-7 pursuant to the Act’s Import for Export (IFE) provisions. Section 801(d)(3) of the FD&C Act [21 U.S.C. § 381(d)(3)] permits the importation of certain violative drug components that are intended for further processing or incorporation into another product and subsequent export, provided that certain statutory requirements are met. For instance, Sections 801(d)(3)(A)(iv) and 301(w) of the FD&C Act [21 U.S.C. §§ 381(d)(3)(A)(iv), 331(w)] require the initial owner or consignee of a drug component maintain “records on the use or destruction” of the imported drug components. Sections 801(d)(3)(A)(iv) and 301(w) of the FD&C Act also state the initial owner or consignee of the imported drug components must submit these records to FDA upon request. In addition, Sections 801(d)(3)(A)(v) and 301(w) of the Act require the initial owner or consignee submit to FDA upon request “a report that provides an accounting of the exportation or destruction” of the imported drug components.
 
On October 18, 2011, FDA sent you a letter requesting information for Import Entry number N90-0842717-7 under Sections 801(d)(3) and 301(w) of the FD&C Act. FDA requested you provide records on the use or destruction of the imported drugs in Imports Entry number N90-0842717-7. FDA also requested you submit a report that provides an accounting of the exportation or destruction of the imported drugs in Imports Entry number N90-0842717-7. FDA’s October 18, 2011, letter stated if you could not provide the records or report within 14 working days, you were to inform FDA of the reason for the delay and when the records and/or report will be produced. You have not responded to FDA’s request.
 
Your September 16, 2008, IFE notification to FDA identifies Resolution, Inc., “dba Missionary Expeditors,” as the intermediate shipper for Imports Entry number N90-0842717-7. On May 4, 2011, FDA sent Resolution, Inc. a letter requesting information about imports entry number N90-0842717-7.  On July 1, 2011, FDA contacted Resolution, Inc. to follow-up on the Agency’s May 4, 2011, letter requesting records and a report for the imported drugs in Import Entry number N90-0842717-7. Per Resolution Inc.’s request, on July 2, 2011, FDA emailed the firm a copy of FDA’s May 4, 2011, letter. However, Resolution Inc. has not provided the requested records and report for Imports Entry number N90-0842717-7.
 
Section 301(w) of the FD&C Act prohibits “the failure to maintain records or to submit records or reports as required” by Section 801(d)(3) of the Act. You have violated Sections 801(d)(3) and 301(w) of the FD&C Act because you failed to provide FDA upon request: (1) records on the use or destruction of the imported drugs in Imports Entry number N90-0842717-7; and, (2) a report providing an accounting of the exportation or destruction of the imported drugs in Imports Entry number N90-0842717-7. 
 
Related to FDA’s request for information for Import Entry number N90-0842717-7, we are concerned about certain issues identified during FDA’s February and May 2009 inspection of your intermediate shipper’s facility.  For instance, during FDA’s February 9-11, 13, 17, 19, and 23, 2009 and May 6, 2009, inspection of Resolution Inc.’s facility, the agency requested records for various IFE drug entries. Drug components imported under the FD&C Act’s IFE provisions either must be exported or destroyed [See Section 801(d)(3)(A)(iii) of the FD&C Act [21 U.S.C. § 801(d)(3)(A)(iii)]].  Section 301(w) of the Act prohibits “the failure to so export or to destroy” IFE drug components. Based on FDA’s review of the IFE records provided during the inspection, FDA had concerns regarding whether you were in compliance with Sections 801(d)(3) and 301(w) of the FD&C Act by exporting or destroying the drugs imported under the IFE provisions of the Act. We issued our May 4 and October 18, 2011, record requests as a follow-up to determine whether you are complying with the applicable IFE requirements.
 
The above violations are not intended to be an all-inclusive list of your firm’s deficiencies. It is your responsibility to assure you are operating in compliance with all requirements of the federal regulations. You should take prompt action to correct all of the violations noted in this letter and you should establish procedures to assure such violations do not recur. Failure to promptly correct these violations may result in regulatory action, including, without limitation and further notice, seizure and/or injunction.
 
Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
 
Your response should be sent to: Mark W. Rivero, Compliance Officer, at the above address.  If you any questions regarding the content of this letter, please contact Mr. Rivero at (504) 832-1103.
 
Sincerely,
/S/                                                           
Patricia K. Schafer
District Director
New Orleans District