> ## 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.

# Aurolife NC Drug Plant Hit With Form-483
- URL: https://www.fdaweb.com/aurolife-nc-drug-plant-hit-with-form-483/
- Published: 2025-05-30T12:00:00.000Z
- Updated: 2026-09-14T15:13:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159275

FDA has issued Aurolife an [11-item Form FDA-483 ](https://www.fda.gov/media/186635/download?ref=fdaweb.com)following a 3/24-4/10 inspection at its Durham, NC manufacturing facility that cited significant GMP deficiencies. For example, FDA took issue with the responsibilities and procedures applicable to the quality control unit, which are not in writing or fully followed. Specifically, the inspection document says the drug product stability sample testing and control program is deficient because stability samples that are pending testing or have completed testing were uncontrolled in the QC Analytical Lab Room and accessible to all personnel.

FDA also cited Aurolife for not filing Field Alert Reports within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet its specifications. Additionally, the inspection cited the firm for not maintaining its buildings in a clean and sanitary condition “free of infestation by insects and other vermin.”

The agency cited similar GMP deficiencies in a 2020 inspection of Aurolife’s Dayton, NJ facility. A subsequent Warning Letter ([see story](https://fdaweb.com/login.php?sa=v&aid=D5148162&cate=&stid=%241%24Xd1.UN1.%24GZyWPCTUmzUkhf3bmWJI6.&ref=fdaweb.com)) noted that the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. It also failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair. Additionally, the firm failed to establish and follow written procedures for cleaning and maintaining equipment.