FDA 483 - Lynnfield Drug, Inc. dba Freedom Fertility Pharmacy - February 27, 2018

On February 27, 2018, the FDA issued a Form 483 to Lynnfield Drug, Inc. dba Freedom Fertility Pharmacy, a producer of non-sterile and sterile products located at 12 Kent Way, Suite 120F, Byfield, MA 01922-1221. The inspection, conducted from February 6-27, 2018, by Investigator John P. Mistler, identified two observations.

Observation 1 noted that disinfecting agents, cleaning pads, and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile. Specifically, non-sterile wipes were used to clean the interior of the ISO-5 classified areas within the sterile cleanroom suite for aseptic drug product production, with no assessment of this practice.

Observation 2 cited inadequate HEPA filter airflow over areas exposed to sterile product. An air pattern analysis (smoke study) performed on April 12, 2017, for the sterile cleanroom suite and ISO-5 classified areas was deemed inadequate due to faint and intermittent smoke. The ISO-5 areas were not certified under dynamic conditions, and unidirectional airflow was not verified under operational conditions. The smoke studies also failed to include the transfer of starting components, materials, in-process products, or final product into the ISO-5 classified areas.