H & P Industries, Inc. — FDA 483 Findings

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

A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.

Deviations from written specifications are not justified.

Written procedures are not drafted., reviewed and approved by the appropriate organizational units.

A baseline report on FDA Form 3417 or approved electronic equivalent was not submitted following the first MDR report on a device model.

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to asslUe compliance with established specifications and standards.

The written stability testing program is not followed.

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include validation ofthe sterilization process.

Reprocessing was performed without the review of the quality control unit.

Drug products failing to meet established specifications are not rejected.

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and pmity they purport or are represented to possess.

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

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

Written production and process control procedures are not followed in the execution ofproduction and process control functions.

Complaints involving the possible failure of a device and labeling to meet any of its specifications were not evaluated and investigated wbere necessary.

Written MDR procedures have not been developed and implemented.

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, Specifically, • The Infant and AQult Glycerin Suppository filling line is not appropriate for the manufacture ofthe OTC drug products in that there were cracked ejector pins on the glycerin press.

Investigations of a fuilure 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.

Employees engaged in the manufacture and packing ofa drug product lack the training required to perfonn their assigned functions.

Corrective and preventive action activities and/or results have not been adequately documented.

Procedures for finished device acceptance have not been adequately established.

Results ofstability testing are not used in determining expiration dates.