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

This FDA Form 483 was issued to Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy, located at 5832 N Knoxville Ave, Ste E, Peoria, IL 61614-4300, a producer of sterile and non-sterile drug products. The inspection, conducted from July 30, 2018, to August 10, 2018, identified five observations.

Observation 1 noted that the facility's design and/or operation permitted poor material flow, specifically, materials were brought into the ISO 7 Buffer room directly from an unclassified area via a b(4) for sterile processing supplies.

Observation 2 detailed that non-sterile bulk solutions were held for extended periods without supporting documentation for hold time. For example, Alprostadil stock solution, lot 07122018@9, was produced in an uncertified hood and stored for up to b(4) days without b(4) prior to b(4) after use, and was used in multiple sterile product lots.

Observation 3 stated that the firm prepared multi-dose sterile drug products without preservatives, but with extended beyond-use dates. Examples included Acetylcysteine Ophthalmic solutions (45 days frozen/refrigerated) and Tacrolimus in Corn Oil NF Ophthalmic solutions (28 days room temperature).

Observation 4