Anesthesia device maker cited for design controls.

Florida district inspector Kevin Vogel took five days to sort through the Ocala, FL, operations of Zefon International and wrote up several deviations for validation and design control lapses.

The maker of anesthesiology equipment got a three-page 483 (no EIR was provided by the agency) on Aug. 3, 1999 and a warning letter (Doc. 8083W) about five weeks later on Sept. 9. The firm's two-page response dated Aug. 31 did not provide FDA with enough to ward off the warning letter because of a lack of detail regarding the design control problems. The warning letter mentions an Aug. 12 letter, which FDA did not release with the 483.

Vogel teed off with a citation for failure to completely assess "all processes to determine which require process validation/personnel qualification." This was followed by a deviation involving a failure to complete the validation of a radio frequency weld in blood pressure cuff production. These were the first items to crop up in the warning letter, which tinkered little with Vogel's verbiage.

In his Sept. 29, 1999, letter to the Florida District Office, Zefon Vice President Scott Ryan said Zefon had evaluated "all processes...to determine validation requirements and whether appropriate SOP controls for process monitoring and inspection are available." He added that the appropriate SOPs would be implemented by the end of October and that the personnel training finding would have been evaluated and corrected for by the first of December.

Ryan also noted that Zefon had undertaken an expansion of the facility which he stated would be completed in December 1999 that would "allow the placement of the RF (radio frequency) sealing equipment in an environmental[ly] controlled area to facilitate validation of this process." Ryan stated that the validation study would be completed by the end of January 2000 and promised to forward the relevant documents by the end of this past February.

Ryan followed the Sept. 29 letter with another he inked the next day. In that communique, Ryan essentially reiterated Zefon's efforts "to determine validation requirements," and referred to an attachment that summarized the manufacturer's evaluation of validation requirements.

Zefon's blood pressure cuffs proved nettlesome again in the section of the 483 on design and change controls. Vogel commented that the firm did not get around to documenting design control activities in connection with a change to the inner diameter of the blood pressure cuff that Zefon undertook in October 1998.

FDA noted this finding in the warning letter, but offered no further detail. In his Sept. 30 letter, Ryan wrote only that the company was "strongly committed to full implementation" of design control requirements as detailed in FDA's Quality Systems regulations. He also mentioned that company personnel would attend the agency's Quality Systems Inspection Technique workshop in October 1999.

Another design control issue was another lack of documentation for a change of design, this time to the thickness of a tube that Zefon implemented in response to a complaint dated October 2, 1997, the same date as one involving a complaint regarding a blown pediatric anesthesia line. Vogel inked in an annotation on the 483 that indicated the firm would address the matter by the end of October 1999.

FDA did not specifically address this situation in the warning letter. In a letter dated Oct. 29, Ryan stated that Zefon would "update our change control documentation to include change of tubing wall thickness from complaint # 16." He added that Zefon updated its logs on the matter and that he had attached "our current purchasing specification and incoming acceptance criteria for this tubing."

Attempts to contact Zefon for comment were unsuccessful.

Zefon International, Ocala, FL, 7/26-27, 29-30, 8/3/99, Doc. 108875M, $8.50 plus retrieval.

RELATED ARTICLE: The Checklist - Zefon Int'l., Florida

* Design validation