Forest Pharma nets 5-item 483 for faulty lab controls.

Forest Pharmaceuticals, St. Louis, MO, Lenexa, KS, District

Forest Pharmaceuticals, St. Louis, MO, was the recipient of a five-item 483 for laboratory controls not including sound and appropriate test procedures. Investigator Gwyn Dickinson from the Lenexa, KS, District Office performed the audit.

The EIR was unavailable at press time.

Lab controls were faulty in that "the assay method for Elixophyllin KI Elixir is deficient in that system suitability requirements are not specified and the procedure for evaluating analytical data ... is too general in that it does not describe system suitability requirements for this product."

Next, written procedures for cleaning and maintenance of equipment did not include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation, FDA stated.

"The methods for cleaning equipment used in the formulation and filling Lexapro Oral Solution are not described in sufficient detail to ensure routine cleaning is the same as or more stringent than the method used during validation," the FDAer wrote.

Further, "the written methods and/or validated methods are different than the methods described by the operators who routinely perform equipment cleaning." For example, the procedures for cleaning the formulation tanks and filling equipment specified one type of final rinse. However, the current batch record specified another final rinse.

Also, procedures describing the handling of written and oral complaints related to drug products were deficiently written or followed. Specifically the 483 stated, "the complaint procedure is deficient in that it does not include provisions for review by the quality unit, [and] does not require an investigation or describe who is responsible for investigating the complaint or determining the extent of the investigation."

In addition, "the records for components do not include the name of the prime manufacturer if different from the supplier and location of the prime manufacturer," according to the report.

For example, the procedure for receipt of incoming raw materials did not require the name and location of the prime manufacturer to be recorded in receiving records. "There is no documentation of the manufacturer of the raw material ... to ensure this shipment was received from the approved manufacturer. The manufacturer is not identified on the drums of material nor on the certificate of analysis."

Last, "routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance," the 483 stated. Specifically, "the flow meter on the purified water system in the liquid formulation area was not calibrated."

The firm was unavailable for comment. Forest Pharmaceuticals, St. Louis, MO, 8/24-27/04, Doc.109956M, $3 plus retrieval.