H & P Industries, Inc. — FDA 483 Findings

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

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

Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that components conform to appropriate standards of identity, strength, quality and purity.

Equipment for adequate control over air pressure and dust is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.

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 materia] and the drug product.

Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.

Records are not kept for the sanitizing of equipment.

Procedures for the cleaning and maintenance ofequipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.