Supplement Maker Warned by FDA for Misbranding and Procedural Violations

Per FDA News, Sanapac, a dietary supplement manufacturer, was notified by the Food and Drug Administration for GMP violations, adulterated products, and misbranding products after an inspection in 2016. After an inspection in November, FDA inspectors returned the following month and found numerous issues in regards to the lack of written Standard Operating Procedures for[…]

FDA Prioritizing GMP Re-Inspections for High-Risk Dietary Supplement Firms

This article was sparked from reading Josh Long’s post on Insider Law about inspections of Dietary Supplement firms for compliance with Good Manufacturing Practices (GMPs). These firms had previously failed an inspection and were targeted by the FDA as “high-risk”, thus precipitating the need for re-inspection. Josh reports that half of the dietary supplement companies[…]

InstantGMP and Marian Boardley Present Webinar: GMP Compliant Master Batch Records

Cary, NC – In 2014, nearly 10% of 483 observations by the FDA stemmed from issues with Master Batch Records. Improving Master Batch Records can reduce 483s, make completing your batch records easier and ultimately improve the quality of dietary supplements. InstantGMP teams up with consultant Marian Boardley to share advice on writing Master Batch[…]