# FDA 483 - Contract Pharmaceuticals Limited Canada - November 03, 2023

Source: https://www.keypedia.com/records/483/contract-pharmaceuticals-limited-canada/e213dada-8783-40f0-9055-9b6e148e8c4d

> FDA 483 for Contract Pharmaceuticals Limited Canada on November 03, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Contract Pharmaceuticals Limited Canada
- Inspection Date: 2023-11-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Contract Pharmaceuticals Limited Canada in Mississauga, Canada, revealed a significant lapse in quality control procedures. The firm failed to thoroughly investigate the recovery of a highly pathogenic microorganism, Brucella melitensis, during environmental monitoring of a production area. This indicates a serious deficiency in their incident reporting and investigation processes, potentially compromising product safety.

## Related Documents

- [483 - 2023-11-03](https://www.keypedia.com/records/483/contract-pharmaceuticals-limited-canada/ebab7440-da3e-4a25-ac3c-92bd561a31fc)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kristina-l-conroy/d6f2d9e4-f547-4bb2-9531-157b5890fae0)

Company: https://www.keypedia.com/companies/contract-pharmaceuticals-limited-canada/02ec2d1f-df8d-4636-95d2-b548aea571d8

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1