FDA 483 - Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy - August 10, 2018

The FDA Form 483 details observations from an inspection of a facility producing sterile injectable and ophthalmic drug products.

The facility's design and operation permit poor material flow, with materials entering the ISO 7 Buffer room directly from an unclassified area via a redacted opening. This includes sterile processing supplies like redacted syringes, sterile redacted spray bottles, sterile wipes, redacted pharmaceutical grade redacted, and zip-lock bags. This was observed during sterile production of Papaverine, Phentolamine, Alprostadil injectable lots 07302018@18 and 07302018@17 in the ISO 5 hood on July 30, 2018.

Non-sterile bulk solutions are held for extended periods without supporting documentation for hold times. Bulk stock solutions are prepared in an uncertified hood and stored in a redacted as an intermediary stock solution at redacted for up to redacted days without redacted. For example, redacted of Alprostadil stock solution, lot 07122018@9 (Beyond Use Date 08/26/18), produced on July 12, 2018, was used to produce sterile products through redacted in the ISO 5 hood on multiple dates in July 2018, without requiring the intermediary stock solution to be redacted prior to later use.

Multi-dose sterile drug products are prepared with extended beyond