Bella Pharmaceuticals, Inc. — FDA 483 Findings

The firm does not have procedures or processes that provide sufficient control over bulk drug substances and components, for example: A The firm compounds sterile drug products from non-sterile bulk drug substances.

Your firm did not maintain documented production worksheets for any of the compounded sterile drug products shipped to customers including those listed in the below table

Clothing of personnel engaged in the compounding, processing, packing, and holding of drug products pwporting SEE

Procedures designed to prevent mix-ups of drug products have not been established or implemented.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

The labels of your outsourcing facility's dmg products do not include information required by sections 503B(a)(lO)(A) and (B).

Buildings used in the manufacture, processing, packing, or holding of a dmg products purporting to be sterile do not have the suitable size, construction, location to facilitate cleaning, maintenance, and proper operations.

The firm does not have procedures or processes that provide sufficient control and storage over non-sterile glass vials prior to their use in compounding.

The finished product testing for product release does not include: A.

Procedures designed to prevent objectionable microorganisms in drug products required to be sterile are not established, written, or followed.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.