Hybrid Pharma Lands FDA Form 483 Over Sterility, Quality Controls

Hybrid Pharma received a nine-observation Form 483 for a host of sterility and quality control deficiencies.

The FDA found Hybrid Pharma lacked written and established procedures to prevent the contamination of drug products. Additionally, the company has not established or documented test methods to validate the accuracy, sensitivity, stability, specificity, and reproducibility of sterile injectable products.

Agency inspectors observed a reddish and yellowish discoloration on filters in the company’s cleanrooms. Hybrid Pharma has not given a reason for the discoloration and not concluded any investigations into the reason for the discoloration, the FDA said.