Vietnam Suture Maker Warned Over Particle Monitoring
The FDA slapped Mani Hanoi, a Vietnam maker of surgical sutures with attached needles, with a warning letter for particle monitoring slips and other GMP issues.
The company's work instruction required particle monitoring reports to include results for two different particle sizes. However, a report for 2013 failed to include results for one of the particle types, according to the June 11 letter posted online this month.
The FDA suggested the company conduct a retrospective review of historical particle monitoring data to see if environmental conditions were adequate. Mani Hanoi should also address any potential nonconformances related to particle monitoring and provide documentation on the revised instruction, the letter says.
Process validation also drew investigator scrutiny. For one operational qualification, the company lacked documentation supporting its choice of maximum and minimum temperatures. The warning letter followed a March 17-20 inspection of the company’s Tan Huong Commune facility in the Pho Yen District.
The letter goes on to provide several examples of corrective and preventive action failures, including lack of procedures to analyze quality data on customer satisfaction, suppliers, conformity to product requirements, and characteristics and trends of processes and products.
Meanwhile, documentation for verifying the effectiveness of CAPAs was not consistently included in CAPA reports. For example, there was no documentation to show that substitute employees were still properly performing a certain process following retraining and a month of monitoring.
Another CAPA report did not explain why continued monitoring was still necessary after six months of monitoring showed the corrective action was not effective. "The follow-up CAPA states that monitoring would continue for another year but does not provide a rationale for the continuation of monitoring," the letter says.
Finally, the company's device history records for dental sutures with needles and ophthalmic sutures with needles did not identify inspection and/or test equipment used for in-process and finished product testing.
Mani Hanoi could not be reached for comment by press time. The warning letter is available at www.fdanews.com/11-11-14-ManiHanoi.pdf. — April Hollis