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# 11 Violations in Bella Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/11-violations-in-bella-pharmaceuticals-fda-483/
- Published: 2017-07-26T12:00:00.000Z
- Updated: 2026-09-14T22:36:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139232

FDA has released the FDA-483 issued following a 6/10-7/18 inspection at Bella Pharmaceuticals, a Chicago, IL, outsourcing facility. The inspection observations were: 

- failing to establish, write, or follow procedures designed to prevent objectionable microorganisms in drug products required to be sterile;
- failing to maintain documented production worksheets for any of the compounded sterile drug products shipped to customers;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- finished product testing for product release does not include required items;
- buildings used in the manufacture, processing, packing, or holding of a drug product purporting to be sterile do not have the suitable size, construction, or location to facilitate cleaning, maintenance, and proper operations;
- failing to establish or implement procedures to prevent mix-ups of drug products;
- failing to have procedures or processes that provide sufficient control over bulk drug substances and components;
- failing to have procedures or processes that provide sufficient control and storage over non-sterile glass vials prior to their use in compounding;
- clothing of personnel engaged in the compounding, processing, packing, and holding of drug products purporting to be sterile is not appropriate for the duties they perform;
- labeling on the facility’s drug products do not include information required by law.