GMP violations still uncorrected at Edge Biologicals.(Medical Devices)

Edge Biologicals failed to correct deficiencies identified in previous inspections to better conform with GMPs, noted FDA inspector Cherie Parker, during a Jan. 29-Feb. 2, 2007, investigation.

Parker observed that the Memphis, TN, company, which manufactures in vitro diagnostic media that FDA classifies as medical devices, had not submitted a 510(k) for its device. Parker also found that the company had not validated processes for its water system, hood used for aseptic filling and plate pouring in the main processing area, and for its plate pouring room.

Edge Biologicals also did not have written procedures for environmental monitoring of these areas. "Procedures are needed to define what type of monitoring, at what frequency the monitoring should occur, and how the results of the monitoring are to be documented," the inspector wrote.

Parker found no evidence that a quality policy had been written.

The company's "written procedure and the purchase order for procuring media, Petri dishes, test tubes, bottles, other components and services. did not contain a statement of agreement from Edge's suppliers that they would notify the company of changes in products or services that might have a negative effect on the device, the investigator wrote.

The inspection also showed that the company's procedures for acceptance activities were not established and documented. Although the firm conducted visual inspections for container integrity of media and a certificate of analysis, and conducted quality tests on powdered media, "your procedure is inadequate in that it does not define how to verify performance as specified by the manufacturer before production of finished product," Parker wrote.

Edge had a written change control procedure but it was not completely followed, the investigator observed. Changes were made to production procedures without documentation with signatures of approving officials and the date on which the change was approved, Parker stated.

The company informed Parker that the deficiencies identified during the inspection would be rectified within 90 days. FDA notified the firm's owner, Walter Edge, that its response to the Form 483 was inadequate "because no corrective action verification information or documentation was provided with the letter," and invited Edge to meet with the New Orleans District staff to assist the company "in resolving your firm's lack of compliance with Federal regulations," the agency wrote. Edge Biologicals, Memphis, TN, 1/29-2/2/07, Doc. 110127M, $20.50 plus retrieval

Checklist: Edge Biologicals

[check] Device missing 510(k) submission

[check] Written procedures needed

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