Heart device maker St. Jude Medical Inc received a warning letter from the U.S. Food and Drug Administration, which said that various devices of the company manufactured at its Atlanta plant are adulterated.
The health regulator in a letter dated Sept. 30 also warned that the company’s manufacturing, packing, storage and installation practices “are not in conformity” to the current goods and manufacturing practise (CGMP) requirements.
St Jude said in a regulatory filing that the FDA had from June 8 to 26 inspected the company’s Atlanta facility, where it makes heart failure monitor CardioMEMS HF system. (1.usa.gov/1KWuXtN)
St Jude said it would continue to manufacture and ship the product from the Atlanta facility and does not expect customer orders to be impacted.
The St Paul, Minnesota-based company earlier resolved manufacturing issues regarding its Sylmar, California plant in July 2014.
The FDA had then warned the company of serious violations at Sylmar, the plant where the Durata leads for implantable defibrillators are made. Violations included a failure to validate testing methods.
The company’s shares were marginally down at $63.80 in extended trading on Friday.
(Reporting by Rosmi Shaji in Bengaluru; Editing by Maju Samuel)
Source: Reuters Health