The FDA said a 2nd round of inspections last fall at the plant, which produces Teleflex’s Hudson RCI line of sterile water humidifiers and other respiratory devices, found 5 violations of agency regulations.
"Two repeat violations were noted from the previous inspection dated April 19 through May 12, 2010. The repeat observations related to your firm’s failure to address causes of non-conforming product and the failure to validate processes," according to the warning letter. "A follow-up inspection by FDA would have to be conducted to assure that corrections and/or corrective actions are in place."
The violations the FDA flagged include:
- Failure to adequately establish procedures for corrective and preventive action;
- Failure to document when changes or process deviations occur;
- Failure to establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics;
- Failure to conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules;
- Failure to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met;
The FDA said it received letters from Teleflex in October and December of last year and another in February, but deemed the responses "inadequate."
Teleflex had 15 days from its receipt of the March 11 letter to detail "the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again," according to the letter. It was released by the FDA April 16.