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# 7 Observations in MedisourceRx FDA-483
- URL: https://www.fdaweb.com/7-observations-in-medisourcerx-fda-483/
- Published: 2018-11-07T12:00:00.000Z
- Updated: 2026-09-15T00:43:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142761

FDA has released the FDA-483 issued following the 9/12-9/27 inspection at MedisourceRx, a Los Alamitos, CA, outsourcing facility. The seven specific observations on the [document](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm624876.pdf?ref=fdaweb.com) are: 

- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
- clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not appropriate for the duties they perform;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions;
- employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions;
- the control systems necessary to prevent contamination or mix-ups are deficient;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process; and
- the batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing, and holding.