FDA WARNING_LETTER - walfer corporation - March 16, 2020

The FDA issued a Warning Letter to Walfer Corporation dba The Medicine Shoppe Pharmacy following an inspection from March 9-16, 2020. The inspection revealed that drug products produced by the firm failed to meet Section 503A of the FDCA conditions for exemption from certain provisions, including CGMP, adequate labeling, and FDA approval. The firm did not receive valid prescriptions for individually-identified patients for a portion of its drug products.

The facility was cited for serious deficiencies, including insanitary conditions. Investigators observed dead ants and cockroaches, non-microbial contamination (stained balances and hoods), unsealed/cracked/stained ceiling tiles, and inadequate containment/segregation/cleaning for hazardous drug products. These conditions render the drug products adulterated under Section 501(a)(2)(A) of the FDCA.

Furthermore, the firm's ineligible drug products were found to be adulterated under Section 501(a)(2)(B) for significant CGMP violations, specifically failing to maintain clean and sanitary buildings free of vermin (21 CFR 211.56(a)) and failing to clean/maintain/sanitize equipment and utensils (21 CFR 211.67(a)). The ineligible drug products were also misbranded under Section 502(f)(1) because they lacked adequate directions for use for laypersons.

The FDA acknowledged the firm's