FDA 483 - Complete Pharmacy and Medical Solutions, LLC. - January 23, 2019

This FDA Form 483 details multiple observations from an inspection.

**Observation 1** highlights a failure to thoroughly review unexplained discrepancies and out-of-specification results for drug products. Specifically, the firm failed to investigate stability failures for Atropine Sulfate 0.4mg/mL syringe (Lot 33226/H, potency 108% accelerated, 107.8% room temp at day 8), Epinephrine 0.1mg/mL syringe (Lot 34523/C, potency 89.2% at 31 days, 79.9% at 48 days accelerated), and Succinylcholine Chloride 20mg/mL syringe (Lot 32995/C, potency 79.7% at day 63 accelerated).

**Observation 3** notes that drug products lack expiration dates determined by appropriate stability data to ensure quality.

**Observation 4** indicates that specific identification tests are not conducted on components accepted based on supplier reports. The firm does not perform identity testing on any lot of active drug ingredient.

**Observation 5** states that the results of examining packaged and labeled products were not documented in batch records. The firm lacks evidence of visual inspections of sterile drug products after labeling and prior to release, and has no procedure for such inspections.

**Observation 6** points out inadequate air pressure control. The