Page 11 - Supply Chain Security Act News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus? The FDA’s posting of drug GMP warning letters citing product adulteration has substantially decreased in the past several months. Warning letters are generally issued approximately seven months after inspections. The decrease we are now seeing is due to the slowdown of on-site inspections with COVID travel limitations and concerns regarding investigator safety. However, the FDA recently posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters often signal a new enforcement focus or process for the FDA. (For example, when the FDA issued a warning letter to McKesson Corp. in Feb. 2019, it was the first and so far, the only time the agency cited failure to comply with the requirements in the November 2013 Drug Supply Chain Security Act (DSCSA) amendments to the Food, Drug, and C

United statesBarbara ungerYuyao yijia daily chemical co ltdCompounding centers of americaUnger consulting incCompounding centersMckesson corpUnger consultingSupply chain security actFederal foodCosmetic actProfessional compounding centersஒன்றுபட்டது மாநிலங்களில்பார்பரா அஂகர்கூட்டு மையங்கள் ஆஃப் அமெரிக்காஅஂகர் ஆலோசனை இன்க்