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Home » Mississippi Devicemaker Hit for Missing Procedures
Mississippi Devicemaker Hit for Missing Procedures
October 16, 2019
Emilia Resources drew a Form 483 from the FDA for violations at its De Kalb, Mississippi facility.
During an inspection of the facility, the FDA investigator logged three observations related to missing procedures, including the lack of a written procedure for medical device reporting to the agency.
The facility also lacked written complaint handling and purchasing control procedures, the agency said.
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