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# 13 Inspection Observations at Pharmedium Services
- URL: https://www.fdaweb.com/13-inspection-observations-at-pharmedium-services/
- Published: 2018-01-11T12:00:00.000Z
- Updated: 2026-09-14T23:12:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140485

FDA has released the FDA-483 issued following a 11/27/17-12/22/17 inspection at Pharmedium Services, a Sugar Land, TX, drug outsourcing facility. The [form](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm592008.pdf?ref=fdaweb.com) lists these inspection observations: 

- the quality control unit lacks the responsibility and authority to reject all drug products;
- the flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building is not designed to prevent contamination;
- the firm failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- there is a failure to thoroughly investigate any unexplained discrepancy or failure of a batch, regardless of whether the batch has been distributed, or a failure to expand an investigation to assess other batches that may also be affected;
- aseptic processing areas are deficient regarding systems for maintaining any equipment used to control aseptic conditions;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- procedures designed to prevent microbiological contamination of sterile drug products does not include adequate validation of aseptic processing;
- · laboratory controls do not include establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- samples taken of drug products for determination of conformance to written specifications are not representative;
- · input to and output from the computer, related systems of formulas, records, or data are not checked for accuracy;
- drug product labeling does not contain information required by the law and regulations; and
- the facility has not submitted a report to FDA identifying a product compounded during the 12/1/16-5/31/17 reporting period as required by law and regulations.