FDA WARNING_LETTER - ideal specialty apothecary, inc. - August 31, 2017

On June 17, 2019, the FDA issued a Warning Letter to Ideal Specialty Apothecary Inc. dba Ideal Pharmacy, following an inspection from June 19 to August 31, 2017. The inspection revealed serious deficiencies in the firm's sterile drug product manufacturing practices, rendering their drug products adulterated under FDCA Section 501(a)(2)(A).

Key violations included: 1. Aseptic filling of sterile drug products in an unclassified environment with negative pressure. 2. Use of non-sterile cleaning pads and improperly stored sterile wipes in the ISO 5 area. 3. Failure to perform adequate smoke studies under dynamic conditions. 4. Lack of viable air monitoring in the ISO 5 area after HVAC construction. 5. Media fills not performed under challenging conditions, indicating a lack of assurance in aseptic production. 6. Repackaging of Avastin (a biological product) without a biologics license, assigning a beyond-use date exceeding FDA guidance.

The firm's September 19, 2017, response to the FDA 483 was deemed inadequate due to insufficient documentation and unaddressed observations, such as the negative pressure issue and lack of action regarding microbial contamination. The FDA strongly recommended a comprehensive assessment of operations by a third-party consultant. The firm must respond within fifteen working days with corrective actions and supporting documentation, or face potential