H & P Industries, Inc. — FDA 483 Findings

Written production and process control procedures are not documented at the time of performance.

Individuals responsible for supervising the processing and holding of a drug product lack the education to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

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

Actual yield and percentages of theoretical yield are not detennined at the conclusion of each appropriate phase of manufacturing of the drug product.

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

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

Procedures for corrective and preventive action have not been established.

Procedures to ensure that all purchased or otherwise received product and servi~es conform to specified requirements have ·not been established.

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

Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.

The quality control unit Facks the responsibility and authority to approve all drug products.

Employees engaged in the processing and holding of a drug product lack the education required to perform their assigned functions.

Results of stability testing are not used in detennining expiration dates.

Written procedures for sanitation are not followed.

Each Jot of a component, drug product container, and closure that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.

Procedures for finished device acceptance have not been established.

The production area air supply lacks an appropriate air filtration system.

Control procedures are not established which monitor the output and 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.

Drug products are not quarantined before being released by the quality control unit.

Drug products failing to meet established specifications are not rejected.

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Laboratory records do not include the lot number or other distinctive code of the sample.

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

Established sampling plans are not followed.

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

Investigations of an unexplained discrepancy and 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.

Control procedures fail to include adequacy ofmixing to assure uniformity and homogeneity.

Examination and testing ofsamples is not done to assure that in-process materials confonn to specifications.

The written stability testing program is not followed.

Procedures for monitoring and control of process parameters for a validated process have not been adequately established.

Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.

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

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Reports of analysis from component suppliers are accepted in lieu of testing each component for confonnity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Deviations from written production and process control procedures are not recorded and justified.

Procedures describing the warehousing of drug products are not established and followed.

Procedures to prevent contamination ofequipment or product by substances that may have an adverse effect on product quality have not been adequately established.

Deviations from written specifications and sampling plans are not justified.

Written procedures are not followed 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.

The number of qualified personnel is inadequate to perform and supervise the manufacture, processing, packing, and holding of each drug product.

The plumbing system contains defects that could contribute to the contamination of drug products.

The drug product is not identified with a lot or control number that permits the determination of the history ofthe manufacture and control of the batch.

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

The batch records do not record the distinctive identification nwnber to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.