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Terumo BCT has received a Form 483 citing manufacturing problems with incoming product acceptance and environmental controls on its blood collection systems. Read More
Western Enterprises/Scott Fetzer Company received an FDA warning letter after averaging its suppliers’ quality ratings with its delivery ratings, resulting in a higher overall rating for some suppliers. Read More
The FDA has cited Zoll Manufacturing for failing to adequately validate its Class III medical Life Vest, noting that “approximately half of all treatments delivered to patients are inappropriate shocks,” according to a recent warning letter. Read More
The FDA has warned Ambco Electronics after the devicemaker failed to correct deficiencies noted during a California Department of Public Health inspection and an earlier FDA inspection. Read More