> ## 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.

# Contract Pharma Cited on Environmental Issue
- URL: https://www.fdaweb.com/contract-pharma-cited-on-environmental-issue/
- Published: 2024-04-03T12:00:00.000Z
- Updated: 2026-09-14T14:27:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156696

FDA has issued Contract Pharmaceuticals Limited a [Form FDA-483](https://www.fda.gov/media/177488/download?attachment&ref=fdaweb.com) citing one observation after its Mississauga, Canada facility was inspected 10/2023\. FDA investigators cited the firm for failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Specifically, the agency said Contract Pharma was notified that a highly pathogenic microorganism was recovered during environmental monitoring of the production area, but an incident report (IR) was not initiated to conduct a documented investigation of the result.

*Brucella melitensis* was recovered from an air sample taken on 08/02/2022 in the firm’s wash-up room, which is where production equipment is cleaned, FDA says. The firm’s 2022 Environmental Monitoring Annual Trend Report states *Brucella melitensis* is considered non-objectionable, “however the identification report from your third-party contract laboratory received by your quality unit on 08 /24/2022 states the microorganism is highly pathogenic,” it says.