> ## 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.

# 6 Observations on Innovative Compounding FDA-483
- URL: https://www.fdaweb.com/6-observations-on-innovative-compounding-fda-483/
- Published: 2020-03-26T12:00:00.000Z
- Updated: 2026-09-14T16:09:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Drugs, #legacy-id-D5146421

FDA has just released the FDA-483 issued following a 10/2-12/18/17 inspection at Innovative Intrathecal Solutions, doing business as Innovative Compounding Pharmacy, a Marietta, CA, producer of human and veterinary drug products. Specific observations on the form were: 

- procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process;
- failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failing to use results of stability testing in determining appropriate storage conditions and expiration dates; and
- failing to laboratory test each batch of drug product purporting to be sterile to determine conformance to such requirements.