Bocchi's Sanitation Flies In Face Of Regs, FDA Finds Following Medline Recall
Warning letter to Bocchi Laboratories details violations of FDA regulations agency inspectors found in an inspection of firm's facility from late March through early June 2018 "in response to an outbreak of Burkholderia cepacia associated with" a cleanser it manufactures. In addition to product adulteration due to microbial contamination, FDA found Bocchi in violation of drug GMPs because products were labeled with indications rendering them drugs under FDA regulations.
You may also be interested in...
Sun Pharmaceutical, P&L Developments and Preferred Pharmaceutical made OTCs for customers including CVS, Target and Walgreens. Latest updates to FDA recalls database also includes polypeptide- and colostrum-containing immunity support supplements made by APS BioGroup and Alterna anti-aging, moisture-replenishing conditioning milk and cream marketed by Henkel Corp.
McDaniel Life-Line recalls its Indian Herb supplement after FDA determined it was marketed without an NDA for claims including "blood disorders." For third time in less than a year, John Paul Mitchell Systems brand and other shampoos recalled by manufacturer Bocchi Labs due to potential contamination; other health, beauty and wellness product recalls.
UK pharma announced that in 2021 it will close its manufacturing facility in Carlisle, PA, where around 260 people are employed making the Emergen-C line. It will move the manufacturing to its Guayama, PR, facility.