FDA 483 - OurPharma LLC - September 27, 2024

This FDA Form 483 details observations from an inspection of an outsourcing facility.

**Observation 1** notes the firm's failure to establish adequate written procedures for production and process controls. Specifically, the firm changed manufacturers for Fentanyl Citrate, USP (November 2023) and Morphine Sulfate, USP (February 2024), both active pharmaceutical ingredients (APIs) used in various drug products (e.g., Fentanyl Citrate and Morphine Sulfate formulations). No documentation of change control or assessment of potential impact on product quality, including test methods for assay, bioburden, sterility, and product stability, was found.

**Observation 2** identifies deficiencies in aseptic processing areas regarding HEPA-filtered air supply under positive pressure. Positive pressure was not consistently maintained between rooms of different classifications when doors were opened (e.g., between ISO 7 Ante Rooms and ISO 8 corridor, and ISO 8 corridor and unclassified Changing Room). The firm had not performed a risk assessment or smoke studies to demonstrate that lower quality air does not enter higher quality air areas.

**Observation 3** states that drug product labels from the outsourcing facility do not include information required by section 503B(a)(10)(A) of the FD&C Act.

**Observation 4** indicates that drug product containers do not include information required by section 503B(a)(10)(B