Bocchi's Sanitation Flies In Face Of Regs, FDA Finds Following Medline Recall
Executive Summary
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...
Store Brand Cough/Cold OTCs, Alterna Conditioners Among Recent Recalls
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.
'Blood Disorders' Supplement, More Bocchi Labs Hair Care Products Recalled
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.
California Bill To Age-Restrict Sales Of Diet Pills Further Along Than Other States’ Legislation
CA, MA and NJ legislatures remain in session with bills active proposing regulations similar to NY law effective 22 April requiring retailers, including online, to ask for proof of age when customers buying consumer health products containing ingredients labeled or promoted for weight loss and bodybuilding benefits appear younger than 18.