FDA WARNING_LETTER - Park Avenue Compounding - August 14, 2014

The FDA issued a Warning Letter to SSM Health Care St. Louis dba SSM St. Clare Health Center, an outsourcing facility, following an inspection from August 4-14, 2014. The inspection revealed serious deficiencies in sterile drug product production, putting patients at risk.

Violations include insanitary conditions, such as an operator using an IV bag dropped on the floor, and failure to demonstrate adequate protection of the ISO 5 area. The facility also failed to meet 503B conditions, leading to adulterated and misbranded drug products. Specific CGMP violations cited include inadequate personnel clothing, lack of validated aseptic processes, insufficient environmental monitoring, incomplete batch records, and failure to investigate out-of-specification results.

Additionally, compounded drug product labels lacked required information like dosage form, compounding date, storage instructions, and complete adverse event reporting details (MedWatch phone number). The facility also failed to submit required 6-month compounding reports to the FDA.

The FDA found the facility's August 22, 2014, response to the Form FDA 483 deficient, noting incomplete label corrections, inadequate smoke study documentation, and a policy allowing use of dropped medications. The beyond-use dates for some products lacked supporting data, and media fill procedures were not representative of actual manufacturing.

The FDA recommends a comprehensive assessment of operations, potentially with a third-party consultant, to ensure CGMP compliance. Failure to correct violations