New England Home Therapies, Inc – FDA 483, Jan 27, 2016

This FDA Form 483 document outlines multiple deficiencies observed during an inspection of a drug product manufacturing facility.

**Facility and Operations:** The facility processes drug products, including those purporting to be sterile and penicillin.

**Violations and Observations:** * **Personnel Clothing:** Clothing worn by personnel engaged in drug product processing is inappropriate for their duties. * **Microbiological Contamination Prevention (Sterile Products):** Procedures to prevent microbiological contamination of sterile drug products are not established or followed. Additionally, these procedures lack validation of the sterilization process. * **Equipment and Utensils Maintenance:** Equipment and utensils are not maintained at appropriate intervals, risking contamination that could alter drug product safety, identity, strength, quality, or purity. Routine calibration of mechanical and electronic equipment is not performed according to a written program. * **Aseptic Processing Areas:** * The system for monitoring environmental conditions is deficient. * The system for cleaning and disinfecting the room and equipment to produce aseptic conditions is deficient. * **Penicillin Processing:** Operations involving penicillin are not performed in facilities separate from those used for other human drug products. * **Building Maintenance:** Buildings used for drug product processing are not maintained in a good state of repair. * **Discrepancy Review:** There is a failure to thoroughly review unexplained discrepancies, regardless of batch distribution status. * **Complaint Handling:** Procedures for handling written and oral