H & P Industries, Inc. — FDA 483 Findings

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.

Procedures for the cleaning and maintenance of equipment are deficientregarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

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.

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.

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

Records are not kept for the sanitizing of equipment.

Drains are not provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer.

Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product Specifically, several leaks were noted in the high purity water system, including one from a sample port atHDIOlwhich is hard plumbed to the wall mounted tester unit, dripping at an observed rate of several drops per second.

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.