St. Jude Medical Warned for GMP Lapses at CardioMEMS Plant
St. Jude Medical revealed in an SEC filing that it received a Sept. 30 warning letter for GMP deficiencies at its Atlanta, Ga., facility following a June 8 to 26 inspection related to the firm’s heart failure monitor, the CardioMEMS HF System.
The warning letter, which is not yet posted on the FDA’s website, was included as an exhibit to the SEC filing.
According to the warning letter, the firm did not maintain an effective CAPA system and did not investigate known problems to determine root cause.
For example, the firm opened a CAPA for incorrect serial numbers on CardioMEMS hospital units on Nov. 26, 2014, but the CAPA wasn’t closed, and the firm filed for an extension during the inspection. The due date for completion of the investigation was originally Jan. 18.
Similarly, the firm opened a CAPA Nov. 5, 2014, for defects found in coated sensors, which included coating imperfections and fractured glass, but the investigation was never completed, even though the deadline was Dec. 5, 2014. The firm requested an extension during the inspection.
The company said the complete effectiveness verification and closure target date for the CAPA is January 2016. The FDA requests copies of activities related to these actions so they agency may evaluate them.
Investigators also observed that sterilization validation activities weren’t documented for the heart failure device, and annual validation activities were not being performed.
The silicone coating process also was not adequately validated, and the firm only conducted one qualification study. “[H]owever, there is no documentation of the established parameters used at processing and no documentation showing repeatability of the HF coating process,” according to the letter.
Finally, the FDA said St. Jude hadn’t established procedures for quality audits.
St. Jude spokesman Justin Paquette tells IDDM that at the time of the June 2015 CardioMEMS postapproval inspection, the company was transitioning the Atlanta facility into its global quality system.
“In response to the observations, we submitted our corrective actions to FDA in July and provided updates in August and September.
“The FDA has acknowledged that the company appears to have adequately addressed the majority of the FDA observations,” he adds.
Paquette says the FDA had not identified any specific concerns about the performance of CardioMEMS.
“We will continue manufacturing and shipping product from the Atlanta, Ga., facility, and customer orders are not expected to be impacted while we work to resolve the FDA’s concerns,” he says.
Read the warning letter here: www.fdanews.com/10-12-15-StJudeWL.pdf. The Form 483 is at www.fdanews.com/10-12-15-StJude483.pdf. — Tamra Sami