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# SterRx Inspection ‘483 Released
- URL: https://www.fdaweb.com/sterrx-inspection-483-released/
- Published: 2017-05-31T12:00:00.000Z
- Updated: 2026-09-14T22:26:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138823

FDA has released the FDA-483 inspection [report](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm558417.pdf?ref=fdaweb.com) from a 2/27-3/17 agency inspection at SterRx, a Plattsburgh, NY, outsourcing facility. The inspection observations were: 

- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
- results of stability testing are not used in determining expiration dates; and
- the labels of the facility’s drug products are deficient.