FDA Slaps St. Jude Medical with Warning Letter for Atlanta Facility
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.
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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.
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