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.
 

The Delano Co., dba LifeLink Grover Beach, CA (9/7): FDA inspected the firm in April, and after a subsequent review of product labels and statements contained on company Web sites, determined that its marketed products are unapproved drugs. The inspection also cited the form for significant GMP violations for dietary supplements.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm626573.htm

Mylan Pharmaceuticals Canonsburg, PA (11/9): FDA inspected the firm’s Morgantown, WV facility in April and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination. The company also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. And, the firm failed to follow written procedures for production and process controls.https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm626360.htm