FDA 483 - Liberty Drug & Surgical - May 22, 2015

The FDA Form 483 details numerous deficiencies observed during an inspection of a drug manufacturing facility. The facility's design and operations are not preventing contamination. Raw materials, including non-sterile IV bags and containers, are handled in an uncontrolled pharmacy area, wiped with non-sterile materials, and transferred into ISO 7 and ISO 6 clean rooms without adequate sanitization. A non-sterile swab was used on IV bag ports in an ISO 5 laminar flow hood.

Procedures to prevent microbiological contamination are not established or followed; for instance, an IV bag that fell on the floor was still used for a patient prescription. The ISO 7 Anteroom is undersized and contains a sink with a non-potable water source.

Aseptic processing areas lack proper systems for maintaining equipment and monitoring environmental conditions. Smoke studies are not performed under dynamic conditions. Routine environmental monitoring (viable air, non-viable air, surface contact plates) is not conducted, with an outside lab performing it only quarterly. Viable and non-viable air monitoring is absent in the ISO 5 laminar flow hood, and personnel fingertip monitoring is not routine.

Personnel gowning is inappropriate, consisting of non-sterile lab coats, and sterile glove donning was observed to compromise sterility. Cleaning and disinfecting procedures are deficient, with non-sterile wipes stored improperly.

The stability program is inadequate; beyond-use dates for Doxycycline and 17-Hydroxyprogesterone were established without