FDA WARNING_LETTER - Medi-Fare Drug - January 18, 2013

On December 10, 2012, to January 18, 2013, the FDA inspected Medi-Fare Drug & Home Health Center, Inc., observing significant violations. The firm produced drug products without valid prescriptions for individually-identified patients and exhibited serious deficiencies in sterile drug product manufacturing, risking contamination. These issues were noted on an FDA Form 483.

The FDA held a teleconference on February 28, 2013, expressing concerns about the aseptic fill area's design, which was (b)(4) and used for non-sterile activities, increasing contamination risk. The firm agreed not to resume sterile drug production until corrective actions were implemented.

The firm's drug products, produced without individual prescriptions, do not qualify for exemptions under section 503A of the FDCA or FDA's Compliance Policy Guide 460.200. Consequently, these drugs are unapproved new drugs and misbranded, violating sections 505(a) and 502(f)(1) of the FDCA.

Furthermore, the firm's manufacturing practices violate Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering the drugs adulterated under section 501(a)(2)(B) of the FDCA. Specific CGMP violations include: 1. Failure to establish adequate air supply and