Walfer Corporation dba The Medicine Shoppe Pharmacy

Warning LetterClosed

Wayne Wallace Owner Walfer Corporation dba The Medicine Shoppe Pharmacy 3524 B Tamiami Trl Port Charlotte , FL 33952-8100 United States 0703@medicineshoppe.comIssued Sep 17, 2021Office of Pharmaceutical Quality Operations, Division II

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations4

Issue DateSep 17, 2021

Product TypeDrugs

StatusClosed

Closeout LetterSep 26, 2022

Letter Details

Firm: Walfer Corporation dba The Medicine Shoppe Pharmacy
Location: Wayne Wallace Owner Walfer Corporation dba The Medicine Shoppe Pharmacy 3524 B Tamiami Trl Port Charlotte , FL 33952-8100 United States 0703@medicineshoppe.com
FEI Number: N/A
Country: United States
Issue Date: September 17, 2021
Issuing Office: Office of Pharmaceutical Quality Operations, Division II
Product Type: Drugs
Status: Closed
Closeout Letter: September 26, 2022

Summary

Walfer Corporation dba The Medicine Shoppe Pharmacy, a compounding pharmacy in Port Charlotte, Florida, produced adulterated drug products that failed to meet the exemption requirements under Section 503A of the Federal Food, Drug, and Cosmetic Act. FDA investigators found serious deficiencies in the pharmacy's manufacturing practices during a March 2020 inspection, including production of sterile compounded products without valid prescriptions for individually-identified patients and failure to comply with current good manufacturing practice (CGMP) standards. The violations put patients at risk, prompting the pharmacy to initiate recalls of all drug products within expiry and cease sterile product manufacturing.

Walfer Corporation dba The Medicine Shoppe Pharmacy FDA Warning Letter, September 17, 2021