FDA WARNING_LETTER - Lee & Company - February 21, 2013

An FDA inspection of Sunnymede Pharmacy, Inc. (dba Lee and Company and Lee Pharmacy) from February 19-21, 2013, revealed significant violations. The firm was producing drug products without valid prescriptions for individually-identified patients, which means these drugs are not exempt under FDCA section 503A and are considered unapproved new drugs and misbranded.

Furthermore, the inspection found serious deficiencies in sterile drug product manufacturing practices, rendering these products adulterated. Specific issues included failure to demonstrate adequate protection of ISO 5 areas, lack of written procedures to prevent microbiological contamination, inadequate environmental monitoring in aseptic processing areas, and insufficient stability testing programs to determine expiration dates. These constitute significant Current Good Manufacturing Practice (CGMP) violations.

The FDA cited violations of FDCA sections 505(a) (unapproved new drugs), 502(f)(1) (misbranded drugs due to inadequate directions for use), 501(a)(2)(A) (adulterated due to insanitary conditions), and 501(a)(2)(B) (adulterated due to CGMP violations). The firm's March 14, 2013, response to the FDA Form 483 was deemed insufficient, as it referenced USP-NF General Chapter <797> compliance but did not address the CGMP requirements for drugs produced without patient-specific prescriptions.