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An FDA inspection at a medical device facility in Akita, Japan revealed nonconformities in process and software validation, as well as complaint handling and device history records. Read More
The FDA cited drug manufacturer Immunostics over CAPA procedure issues, inadequate complaint handling, calibration deficiencies and other problems at the firm’s Eatontown, New Jersey facility. Read More
The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant CGMP violations. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
“We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results,” CDRH’s Donald St. Pierre said. Read More
The firm’s recordkeeping made it unclear if the issues described in customer complaints represented adverse events that should have been reported to the FDA. Read More
None of the company’s complaints from 2016 or 2017 reviewed by the FDA had been evaluated to determine whether they should be reported to the agency as adverse events. Read More
Westone Laboratories’ manufacturing facility in Oregon drew a Form 483 from the FDA for significant quality system nonconformities and equipment calibration issues. Read More
Palo Alto Health Sciences drew a Form 483 from the FDA for inadequate CAPA and complaint procedures, and for incomplete internal auditing and supplier profiles. Read More