Latest FDA Warning Letters
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Becton Dickinson Franklin Lakes, NJ (1/11): FDA inspected the firm 7/2017 and determined that the firm did not gain clearance for device modifications to its BD Vacutainer Blood Collection tubes. For example, the firm made significant changes to the formulation of the rubber stoppers used for the BD Vacutainer tubes, and such changes could significantly affect the safety or effectiveness of the devices. The inspection also cited the firm for GMP deviations related to its devices. For example, the agency says the firm’s design validation fails to ensure that the device conforms to defined user needs and intended uses and fails to include testing of production units under actual or simulated use conditions.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592062.htm
Delta Laboratories Somersby, New South Wales, Australia (12/19/2017): FDA inspected the firm 3/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm also failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport to possess.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm591826.htm
Schrofner Cosmetics Salzburg, Austria (12/20/2017): FDA inspected the firm 7/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish an adequate quality control unit and applicable procedures. The firm also failed to establish and follow adequate written procedures for preparing master production and control records designed to assure uniformity from batch to batch.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm591990.htm
Shanwei Honghui Daily Appliance Co. Shanwei, Guangdong Province, China (12/5/2017): FDA inspected the firm 7/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to clean, maintain, and sanitize or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination. The firm also failed to follow written procedures for production and process control.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm591795.htm
Wuhan Chinese Moxibustion Technology Wuhan, Hubei, China (12/18/2017): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, and the authority to review all production records to assure that no errors have occurred. The firm also failed to prepare master production and control records designed to assure uniformity from batch to batch.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm591840.htm
Yicheng Chemical Corp. Changzhou, Jiangsu, China (1/2): FDA inspected the firm 7/2017 and cited significant GMP deviations for its active pharmaceutical ingredients (API). For example, the firm failed to package drugs under appropriate conditions to avoid potential cross-contamination. The firm also failed to use separate facilities to manufacture its API.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592373.htm