Clarcon Biological Chemistry Laboratory — FDA 483 Findings

Procedures describing the handling of written and oral complaints related to drug products are not written or followed.

Records are not kept for the maintenance, cleaning, sanitizing, and inspection ofequipment.

Procedures describing the warehousing ofdrug products are not established.

There is a lack of written procedures assigning responsibility, providing cleaning schedules, and describing in sufficient detail the methods, equipment and materials to be used for sanitation.

The master production and control records for each batch size ofdrug product are not prepared, dated, and signed by one person with a full handwritten signature.

Procedures designed to assure that correct labeling are used for drug products are not written.

Employees are not given training in current good manufacturing practices.

There is no quality control unit.

Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.

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

All compounding and storage containers and major equipment used during the production ofa batch of drug product is not properly identified at all times to indicate contents and the phase of processing ofthe batch.

The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.

Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection ofcomponents, drug product containers, and closures.

Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the identity and strength of each active ingredient prior to release.

A sample which is representative ofeach lot in each shipment ofeach active ingredient is not retained.

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

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

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.