Walfer Corporation dba The Medicine Shoppe Pharmacy
FDA issued a warning letter to Walfer Corporation dba The Medicine Shoppe Pharmacy (Port Charlotte, FL) following a March 2020 inspection that found the compounding pharmacy producing drug products without valid patient-specific prescriptions, under insanitary conditions (vermin, stained equipment, unsealed ceiling tiles), and in violation of CGMP regulations. The facility also compounded what appeared to be essentially copies of commercially available drug products (e.g., Oxycodone HCl 30mg capsules). FDA found the drug products adulterated and misbranded under the FDCA, and the firm had already recalled all in-expiry products and ceased sterile compounding. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health
your firm compounded drug products that appear to be essentially copies of commercially available drug products (e.g., Oxycodone Hydrochloride 30mg capsules)
your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced
Required actions (4)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing if you have taken any specific steps to correct the violations cited in this letter.
You should take prompt action to correct the violations cited in this letter.
Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure and injunction.
you should notify this office fifteen (15) working days prior to resuming production of any sterile drugs in the future
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