FDA 483 - H & P Industries, Inc. - January 07, 2011

This FDA Form 483 details numerous deficiencies across quality systems, manufacturing, and personnel at an unnamed facility producing drug products, including sterile and non-sterile items.

**Quality System and Control Issues:** The facility lacks established procedures for corrective and preventive actions (CAPA), finished device acceptance, and ensuring conformity of purchased products/services. The Quality Control (QC) unit's responsibilities and authority are not fully followed, specifically lacking the authority to approve all drug products, and failing to reject products not meeting specifications. Control procedures for monitoring process parameters, validating processes, and preventing contamination are inadequate or non-existent. There is no established system for monitoring output and validating manufacturing processes to control variability.

**Manufacturing and Process Control Deficiencies:** Processes whose results cannot be fully verified are not validated. Mixing adequacy to ensure uniformity is not controlled. Deviations from written specifications and sampling plans are not justified or followed. Production and process control procedures are not documented at the time of performance, and deviations are not recorded or justified. Master production and control records are not properly prepared, checked, and signed. Batch records lack equipment identification numbers, and actual/theoretical yields are not determined. Procedures to prevent microbiological contamination, including validation of sterilization processes, are inadequate.

**Laboratory and Testing Failures:** Laboratory controls lack scientifically sound test procedures. Drug products are not tested for conformance to final specifications prior to release. The written stability testing program is not followed, and stability results are not