Jennifer Yoakum
Co-Owner and Pharmacist-In-Charge
Med Shop Total Care, Inc.
470 E Loop 281
Longview , TX 75605-7939
United States
(b)(6)FEI 3002835459Issued Mar 18, 2022Office of Pharmaceutical Quality Operations, Division II
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3002835459.
Violations0
Issue DateMar 18, 2022
Product TypeDrugs
StatusClosed
Closeout LetterOct 24, 2023
Letter Details
Firm
Med Shop Total Care, Inc.
Location
Jennifer Yoakum
Co-Owner and Pharmacist-In-Charge
Med Shop Total Care, Inc.
470 E Loop 281
Longview , TX 75605-7939
United States
(b)(6)
FEI Number
3002835459
Country
United States
Issue Date
March 18, 2022
Issuing Office
Office of Pharmaceutical Quality Operations, Division II
Product Type
Drugs
Status
Closed
Closeout Letter
October 24, 2023
Summary
Med Shop Total Care, Inc., a compounding pharmacy in Texas, was cited for producing adulterated sterile drug products that violated federal manufacturing standards and put patients at risk. During a July 2021 inspection, FDA investigators identified serious deficiencies including inadequate product evaluation after microbial contamination was detected in the ISO 5 aseptic processing area, improper hand sanitization procedures by operators, and failure to establish sufficient contact time for disinfecting agents. These violations indicated the drug products were prepared under insanitary conditions that could have resulted in contamination with filth or rendered them injurious to health.
Med Shop Total Care, Inc. FDA Warning Letter, March 18, 2022
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