> ## 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.

# Four FDA-483s Released
- URL: https://www.fdaweb.com/four-fda-483s-released/
- Published: 2024-02-01T12:00:00.000Z
- Updated: 2026-09-14T14:21:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156267

FDA has released the forms FDA-483 issued following inspections at four drug manufacturers in three countries. The specific inspection observations for each manufacturer were:

- [Alvotech Hf](http://www.fda.gov/media/175830/download?attachment&ref=fdaweb.com), Reykjavik, Iceland —
  - inadequate environmental/personnel monitoring for a redacted building filling line;
- [AGC Biologics](http://www.fda.gov/media/175834/download?attachment&ref=fdaweb.com), Bothell, WA —
  - written records of investigations into unexplained discrepancies, the failure of a batch or any of its components to meet specifications, do not always include the appropriate conclusions and follow-ups;
  - failing to establish adequate procedural controls to protect the electronic data acquisition and manufacturing control systems used for DS manufacturing in a redacted building at the AGC Biologics Bothell facility;
  - lack of assurance that the drug substance manufacturing operations are appropriately designed to ensure the prevention of contamination of equipment or product by environmental and processing conditions that would be expected to harm product quality;
  - standard operating procedures or work instructions are not followed or are inadequate; and
  - the firm’s quality unit’s oversight of good manufacturing practice manufacturing operations is inadequate.
- [Baxter Pharmaceuticals India Pvt Ltd](http://www.fda.gov/media/175813/download?attachment&ref=fdaweb.com), Ahmedabad, Gujarat, India —
  - failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
  - failing to clean and maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
  - failing to establish written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product;
  - equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance;
  - failing to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
  - failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
  - failing to follow procedures for the preparation of master production and control records;
  - deficient batch production and control records in that they do not include in-process control results; and
  - laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.
- [Eugia US Manufacturing](http://www.fda.gov/media/175809/download?attachment&ref=fdaweb.com), East Windsor, NJ —
  - failing to have a quality unit;
  - aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
  - buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size and construction to facilitate cleaning, maintenance, and proper operations;
  - failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel;
  - input to and output from the computer and records or data are not checked for accuracy;
  - equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use;
  - aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
  - evidence or reserve drug product sample deterioration was not investigated;
  - laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality, and purity; and
  - failing to have written procedures that describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures.