> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 4 Observations in SSM Health Care Inspection
- URL: https://www.fdaweb.com/4-observations-in-ssm-health-care-inspection/
- Published: 2022-01-13T12:00:00.000Z
- Updated: 2026-09-14T17:28:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150930

FDA has released the FDA-483 issued following a 9/16-9/28/21 inspection at SSM Health Care St. Louis, doing business as SSM St. Clare Health Center, a Fenton, MO, outsourcing facility. The four inspection observations were: 

- written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed;
- written procedures are lacking that describe in sufficient detail the receipt, identification, texting, approval, and rejection of components, drug product containers, and closures; and
- the labels of the outsourcing facility’s drug products are deficient.