Inspections, Compliance, Enforcement, and Criminal Investigations
Advanced Specialty Pharmacy dba Meds IV 3/16/12
Department 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
March 16, 2012
WARNING LETTER NO. 2012-NOL-15
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Edward Cingoranelli, Owner
Advanced Specialty Pharmacy dba Meds IV
3985 Parkwood Road, Suite 109-311
Bessemer, Alabama 35022-5690
Dear Mr. Cingoranelli:
Based on our March 23 and 25, 2011, inspection of your pharmacy, Advanced Specialty Pharmacy dba Meds IV, located at 102 Oxmoor Road, Suite 118, Birmingham, Alabama, the Food and Drug Administration (FDA) has determined several lots of drug products were adulterated within the meaning of Section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 351(a)(2)(A)] because the Total Parenteral Nutrition (TPN) drug products were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health.
Furthermore, the TPN drug products made by your firm were misbranded within the meaning of Section 502(a) of the Act [21 USC 352(a)] because their labeling was false or misleading. The products were further misbranded within the meaning of Section 502(j) of the Act [21 USC 3520)] because they were dangerous to health when used in the manner suggested by their labeling.
1. Adulteration Under Section 501(a)(2)(A) [21 USC 351(a)(2)(A)]
On March 14, 2011, (b)(4) notified your firm there were positive cultures of Serratia marcescens in your TPN drug products. Your firm ceased all production of TPN drug products on March 15, 2011.
Testing conducted on your behalf by a contract laboratory of two TPN units (samples ARL numbers 146367-01 and 146368-01 received at the laboratory on March 15, 2011) showed positive growth of Serratia marcescens. In addition, testing conducted by the Centers for Disease Control and Prevention (CDC) identified the presence of Serratia marcescens in your TPN drug products and in the blood cultures of patients to whom your TPN drug products had been administered. Furthermore, the CDC identified Serratia marcescens in environmental samples taken of the anteroom tap water faucet in your facility that was genetically indistinguishable from the same microbial organism found in the TPN isolate from a deceased patient. Therefore, your drug products were adulterated within the meaning of Section 501(a)(2)(A) of the Act.
2. Misbranding Under Sections 502(a) and 502(j) [21 USC 352(a) and 352(j)]
Your TPN drug products indicated they were for parenteral use through a central line only. Drugs with this route of administration are required to be sterile. The hospital testing, CDC testing, and the testing performed on your behalf indicated your TPN drug products were contaminated with Serratia marcescens. Therefore, the contaminated drug products bearing this labeling were misbranded under Section 502(a) of the Act because the labeled directions for administration through a central line misleadingly implied the products were sterile. In addition, these drug products were misbranded under Section 502(j) of the Act because, when used as labeled, they were dangerous to health.
We acknowledge your action of March 24, 2011, to recall all IV products produced from January 1, 2011, to March 23,2011. We understand you have surrendered your pharmacy license for this site to the Alabama State Board of Health. However, if you decide to resume operations, we request you notify this office at least 15 working days before doing so, stating the actions that you will take to correct the noted violations, including an explanation of the steps taken to prevent their recurrence.
Please send your reply to the Food and Drug Administration, Attention: Mark W. Rivero, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 832-1103.
Patricia K. Schafer
New Orleans District
cc: Herb Bobo, R.Ph., Secretary
Alabama State Board of Pharmacy
111 Village Street
Hoover, Alabama 35242