Celltex Therapeutics Corporation — FDA 483 Findings

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.

HCT/Ps made available for distribution were not labeled accurately.

Wshing and toilet facilities are not easily accessible to working areas .

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

Distribution records do not contain the name and strength of the drug product, description of dosage form, name and address of consignee, date and quantity shipped, and lot or control number ofdrug product.

The distinctive code for each lot ofcomponents is not used in recording the disposition ofeach lot.

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

Each lot of components was not appropriately identified as to its status in terms of being quarantined, approved or rejected.

Written records are not made of investigations into the failure of a batch or any of its components to meet specifications.

Routine calibration and checking of equipment is not performed according to a written program designed to assure proper p erformance.