> ## 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.

# 8 Observations on NerPharMa FDA-483
- URL: https://www.fdaweb.com/8-observations-on-nerpharma-fda-483/
- Published: 2025-11-19T12:00:00.000Z
- Updated: 2026-09-14T15:27:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160246

FDA has released the form FDA-483 with eight observations from a 6/16-6/27 inspection at the NerPharMa drug manufacturing facility in Nerviano, Milan, Italy. The inspection observations were:

- procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the aseptic and sterilization process;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications;
- failure to establish adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
- failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
- failure to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel; and
- failure of laboratory controls to include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality, and purity.