Panacea Biotec Pharma Ltd. — FDA 483 Findings

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written and followed.

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitably located to facilitate operations for its intended use and cleaning and maintenance.

There is a failure 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 been already distributed.