FDA 483 - Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy - September 25, 2018

During an FDA inspection, the following observations were made regarding the facility's operations:

The ISO 5 classified area, which houses a laminar air flow hood, is situated within a non-classified room, raising concerns about the surrounding cleanroom's ability to maintain classified conditions. The last certification for this area was on February 22, 2018, and re-certification was due in September. Since September, approximately (b)(4) products have been manufactured on a (b)(4) in this cleanroom.

Furthermore, non-sterilized or non-depyrogenated tools and temporary containers were utilized in sterile drug production. Specifically, there is no assurance that the (b)(4) used to store bulk solution can maintain sterility. This issue impacts several bulk solution vials, including Bupivacaine HCl 40mg/ml lot 09202018@9, Hydromorphone 100mg/ml lot 08902018@54, Morphine 100mg/ml lot 08722018@66, Clonidine HCl 2000 mcg/ml lot 08212018@27, and Hydromorphone 100mg/ml lot 08902018@54. These products are stored (b)(4) and are