Petscript Inc — FDA 483 Findings

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

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform.

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

Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conform ance to the identity and strength of each active ingredient prior to release.

Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

Written procedures are lacking which describe in sufficient detail the receipt, identification , sampling, testing, approval and rejection of components.

Batch production and control records do not include complete information relating to the production and control of each batch .

There is no written testing program designed to assess the stability characteristics of drug products.

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

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed .

Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

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

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not.

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.