California Stem Cell Treatment Center/Cell Surgical Network — FDA 483 Findings

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling pla~1s 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.

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Employees are not given training in current good manufacturing practices.

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

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

The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.

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

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

Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch.

Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Dmg Administration.

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

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.