FDA 483 - Solaris Pharmacy, Inc. - February 26, 2020

This FDA Form 483 document details observations from an inspection concerning the manufacturing of non-sterile drug products, specifically capsules for oral use and Budesonide Inhalation Capsules 320mcg.

The primary observation (a) notes that cleaning agents used for equipment and production areas are unsuitable. On February 19, 2020, a non-sterile technician was observed using a cleaning agent intended for non-food surfaces to clean and disinfect a capsule instrument, despite the firm routinely producing capsules for oral administration. Approximately redacted batches of oral drug product capsules were produced using this method since November 1, 2019.

A second observation (b) on the same date involved the use of an expired sterile cleaning agent by a non-sterile technician to clean and sanitize a capsule instrument in the non-sterile compounding room. This instrument is used in the production of Budesonide Inhalation Capsules 320mcg, Lot #1951, with a Beyond Use Date of 08/19/20.

The document also states that "Non-pharmaceutical grade components are not used in the production of your non sterile drug products. Specifically:" but the specific details following this statement are redacted or incomplete in the provided text. The observations indicate deficiencies in cleaning and sanitization procedures and material suitability for drug product manufacturing.