FDA 483 - Nelson Environmental Technologies, Inc. - July 27, 2023

During an inspection, Nelson Environmental Technologies, Inc., a medical device manufacturer in Stafford, TX, was cited for four observations related to inadequate quality system procedures. The firm failed to properly review and revalidate a changed process, lacked complete procedures for accepting incoming carbon media, and had insufficient process control procedures for manufacturing activities. Additionally, the firm did not ensure equipment, specifically test reagents and strips, was maintained at proper storage temperatures.