The FDA issued Grams Medical a warning letter for sterilization problems related to its reusable cannula tips.
The March 17 letter, posted to the FDA’s website May 3, said the tips are “stored, unwrapped in open wooden bins in a packaging and shipping room.”
Grams Medical did not validate its cleaning and sterilization process for the tips to ensure they were sterile before they were used in an operative setting, or before they were reused, the letter says.
The Costa Mesa, Calif.-based company also lacked a baseline bioburden, or studies to ensure that certain sterilization processes won’t have an adverse effect on the tips, which are used with the Grams Aspirator S-300.
An FDA inspection from Sept. 14, 2015, through Sept. 25, 2015, found Grams had not conducted any management reviews or quality audits.
The firm’s quality manual requires annual management reviews of the quality system and says that internal audits must be conducted and documented. However, it did not specify the frequency or intervals of those audits.
The FDA also rapped Grams for not maintaining documents on specifications for devices, components, the production environment and production processes.
The company also failed to adequately maintain a device master record, the letter said, noting that the firm lacked documentation on production methods and procedures, quality assurance equipment, acceptance criteria, and packaging and labeling instructions for its Aspirator S-300 devices and accessories, according to the letter.
Grams also lacked procedures to ensure device history records are maintained, and it had not developed a medical device reporting procedure for device failures, the agency said.