Warning Letter: Company’s Sole Employee Not Trained

GyNova’s sole employee has no documentation of any training on medical device regulations or current good manufacturing practices that would enable him to evaluate manufacturing and sterilization processes used for his firm’s product, according to a recent warning letter.

GyNova, a specification developer and distributor of vaginal speculums, also failed to document the rationale for a modification to the speculums to prevent them from catching on sutures and slipping during surgical procedures, the letter said.

Two modifications were made to the G*SPEC Articulated Weighted Vaginal Speculums as a result of these problems, along with changes to increase the strength of the handle to resist bending.

The firm made these changes without a design control procedure, the letter said. It also lacked documentation to show a designated individual approved the changes.

GyNova could not be reached for comment by press time. The Jan. 31 letter, posted recently to the agency’s website, is available at www.fda.gov/foi/warning_letters/s6676c.pdf.