FDA WARNING_LETTER - Perry Drugs Inc. - September 09, 2014

The FDA issued a Warning Letter to Perry Drug, Inc. following inspections from August 26-29, 2014, and September 4-9, 2014, identifying serious deficiencies in sterile drug product manufacturing. Violations included inadequate disinfection of materials entering the ISO 5 area, an operator wearing non-sterile gloves with exposed skin and makeup during sterile processing, lack of environmental monitoring (personnel, surface, viable air), and failure to monitor pressure differentials. The firm also failed to demonstrate adequate protection of the ISO 5 area by their hoods. These conditions render sterile drug products adulterated under FDCA Section 501(a)(2)(A).

Additionally, the firm produced domperidone drug products. Domperidone is not subject to a USP/NF monograph, is not an FDA-approved human drug component, and is not on the Secretary's list for compounding, thus making compounded domperidone products ineligible for exemptions under FDCA Section 503A. Consequently, these domperidone products are unapproved new drugs (violating FDCA Section 505(a)) and misbranded (violating FDCA Section 502(f)(1)) because adequate directions for lay use cannot be provided.

The FDA acknowledged the firm's voluntary recall of sterile products and cessation of sterile compounding. The firm's response to the FDA 483, stating adherence to USP <7