IVD maker slapped with 4-item 483 for failing to validate processes, document validation activities.

Failing to "validate processes and document the validation activities and results" netted a four-item 483 for IND Diagnostics, Delta, BC, Canada, following an inspection by Dannie Rowland from FDA's Center for Devices.

IND manufactures in vitro diagnostics for clinical testing, including the MiniStrip HCG One Step Urine Pregnancy Test Strip.

The firm also was slapped with a Dec. 23, 2003, warning letter because it failed to validate processes and document the validation activities and results. This included the date and signature of the people approving the validation and the major equipment validated, the EIR noted.

For example, the 483 stated that "there is no documentation of the process validation activities and results for the MiniStrip HCG Urine Pregnancy Test.

Specifically, FDA wrote: "There is no documented evidence which could be provided describing the monitoring and control methods and data, the dates performed, individuals performing the process, the major equipment used in determining the effectiveness and reproducibility of the production processes used in the manufacture of the buffers and conjugates, and production processes for the MiniStrip HCG Urine Pregnancy Test ..."

The report also noted that acceptance procedures for inspections, tests and other verification activities were not complete. "Specifically, buffers, reagents, including reagents used in the production of in vitro diagnostic devices, have no pre-determined shelf life. Some buffers were observed as bearing upwards to six months earlier preparation dates and were stored in active production inventories."

Also, some of IND's measuring equipment was not suitable for its intended purposes or capable of producing valid results. For example, "the [undisclosed] meter used to conduct pH readings for reagents, conjugates, buffers and controls did not have any calibration sticker or any records for calibration available for review," the 483 stated.

The warning letter cited IND because it failed to "establish and maintain procedures that ensure that all inspection, measuring and test equipment is suitable for its intended purpose and can produce valid results." For example, "the laboratory Mettler scale was observed bearing a calibration date indicating repeat calibration should have been performed four months prior to this inspection."

Further, the EIR stated that the firm had no documentation that "demonstrates that the [undisclosed] water system used in the production reagents, buffers, conjugate and controls used in the manufacture of the MiniStrip HCG Urine Pregnancy Test will consistently produce deionized water which meets its pre-determined quality attributes."

The firm replied in writing: "[We will] contact the water system's supplier and setup an appointment to validate the installation and perform all necessary testing on the equipment. [We will] set up a routine water quality testing program to ensure consistent quality of the deionized water for production use. Training will be provided to employees to reinforce the practice."

The firm also stated: "IND Diagnostics now documents all in-process quality inspection regularly, a library of specific quality testing is available for review. A retrospective validation procedures is required to analyze, on a yearly basis, the routine in-process quality inspection data collected for each batch of buffer and conjugate used," according to the EIR. No comment from the firm was available before deadline.

IND Diagnostics, Delta, British Columbia, Canada, 6/2-5/03, Doc. 109644M, $7.00 plus retrieval.

[check] The Checklist--IND Diagnostics

[check] failure to validate processes

[check] lack of validation documentation