H & P Industries, Inc. — FDA 483 Findings

Rejected in-process materials are not identified and controlled under a quarantine system to prevent their use in manufacturing or processing operations for which they are unsuitable.

Investigations ofa failure ofa batch or any ofits components to meet any of its specifications did not extend to other batches ofthe same drug product..

The number ofcontainers to be sampled is not based upon appropriate criteria.

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.

Records ofthe inspections ofautomatic, mechanical or electronic equipment, including computers or related systems are not maintained.

Reports ofanalysis from component suppliers are accepted in lieu oftesting each component for conformity with all appropriate written specifications, without establishing the reliability ofthe supplier's analyses through appropriate validation ofthe supplier's test results at appropriate intervals.

Strict control is not exercised over labeling issued for use in drug product labeling operations.

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

Written procedures for cleaning and maintenance fail to include description in sufficient detail ofmethods, equipment and materials used and description in sufficient detail ofthe methods ofdisassembling and reassembling equipment as necessary to assure proper cleaning and maintenance.

GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

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

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.

Deviations from written specifications are not justified.

Reprocessing was performed without the approval ofthe quality control unit.

The use of instruments not meeting established specifications was observed.

All major equipment used during the production ofa batch ofdrug product is not properly identified at all times to indicate contents.

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.