Andersen bag-sealing, sterilization slapped.

Andersen Products, Haw River, NC, was cited for a variety of validation deficiencies in a June 28 letter by the Atlanta District Office following an April 19-29 audit of the firm's manufacturing and distribution operations for sterile medical devices including nasogastric tubes, sump pumps/tubes, intestinal tubes and wound drainage tubes.

The agency said the firm failed "to validate the testing equipment used to test the filter integrity of the Shirley WoundDrain's vent filters."

Validation of the bag sealing process using the Packaging Aids Impulse Sealer was deemed incomplete because "no performance testing was conducted to assure that the sealer can consistently produce an acceptable seal over a period of time." FDA said the process is used to seal the primary and secondary bags of sterile devices such as the Shirley Wound Drain.

Validation of the laboratory autoclave also was "incomplete in that no loading pattern(s) was defined for the full chamber challenge." FDA stressed: "It is essential that a product-loading pattern be established to define the maximum/minimum load density requirements for an established (validated) cycle."

The agency noted that no yearly revalidation studies were conducted on the autoclave since 1995, even though required by the validation protocol. FDA remarked: "This autoclave is used in the preparation of sterile microbiological media used in the incubation of biological indicators (BI). The results obtained with these BIs are essential in determining whether the sterilization of routine production loads of medical devices is successful."

Validation of the firm's Sterijet sterilization process also was deficient in that the firm "failed to generate sufficient data to correlate the ethylene oxide (EtO) lethality kinetics between the EtO gas chamber (utilized in sub-lethal cycles) and the Sterijet Aeration Rooms (utilized in half/full cycle EtO sterilization validation studies)," the agency said. Also, there were "several instances" where the final report lacked "conclusionary findings," FDA added.

Finally, Andersen was hit on validation of design changes because it failed to establish procedures for identifying, documenting, validating "or where appropriate" verify, reviewing and approving design changes to existing devices, the letter added.

The agency acknowledged receiving a May 19 letter from Stephanie Wissinger, Acting Director of Quality Assurance, in response to the 483. FDA said: "We have reviewed the proposed corrective actions" and "they appear to adequately address the violations noted. You can refer to that letter in your answer to this one." No comment was received from the firm by deadline. Doc. 7840W.