Surprised by citation, irradiator offers advice.

DeLand & Noell/dba Romagosa Radiation Oncology Center, Lafayette, LA, New Orleans District.

Two 483s, a warning letter and a company response concerning blood irradiation practices at DeLand & Noell, dba Romagosa Radiation Oncology Center, illustrate how closeout discussions with FDA investigators might not always indicate how seriously the observations may be taken by higher-ups in the district office.

The 483s issued by investigator Traci Miller to the firm's two sites showed particular concern about how products were arranged in an accelerator for irradiation. For instance, Miller cited failure to record verification by measure-ment that blood product overlap did not exceed 1.5 centimeters.

Miller also cited procedures that did not specify acceptable overlap nor how the products should be arranged. One of the 483s stated that the firm had not validated the number of units that could be stacked to meet manufacturer instructions; the other objected to unvalidated overlapping.

In addition, Miller found that DeLand's written procedures were inconsistent with a memorandum of understanding with the firm's customers, according to the 483.

A January warning letter indicated that DeLand may have satisfied FDA's concerns about configuration and the memo to customers, but not on the remaining points.

Responding to the warning letter, Director of Medical Physics John Duhon said DeLand had revised its SOPs "to clarify the distinction between stacking and overlapping of blood products" and "added the maximum number of red blood cell bags that can be irradiated at one time."

However, when FDA faulted DeLand for not verifying that a 1.5 centimeter thickness speci-fication for a field size of 10 by 10 centimeters held true for a 32 by 32 centimeter field size, Duhon said he had discussed this with Miller and thought she was satisfied with his responses.

"The conversation was completely theo-retical in nature and no documentation specific to our machines was requested," Duhon wrote, add-ing: "I do not feel that this qualifies as a violation under the regulations or a failure on the part of DeLand and Noell Corporation."

Duhon supplied information on depth dose curves, as FDA requested, then made the agency an offer, which also resembled a comment on the agency's expertise:

"I would like to offer my services if you feel that it would be beneficial to your staff. I would be willing to give talks on the basics of radiation, irradiation equipment, safety issues, current regulations, etc."

No word was available from DeLand as to whether the agency accepted the offer but an FDA spokesman said the inspection was not closed and the agency was not ready to release the EIR.

DeLand & Noell/dba Romagosa Radiation Oncology Center, Lafayette, LA, Dec. 3-4 & 7/98, Doc. 108648M, $4 plus retrieval.