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.
The company has also not conducted disinfectant effectiveness studies to demonstrate that its decontaminants sufficiently reduce bioburden to sterilize the walls, ceilings and surfaces in the company’s cleanrooms.
Other citations noted in the 483 include the observation of personnel donning non-sterile attire in the cleanrooms when manufacturing and processing of drug products and gray duct tape covering ceiling tiles, two light fixtures and HEPA filters.
Routine calibration of automatic and electronic equipment, as well as follow-ups and conclusions on batch failures, have not been performed or documented, the FDA said.
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