GMP Regulatory Newsletter: Summary Scan | Week of 7/8/18

Laws, Regulations, Guidance, and Concept Papers FDA published 6 draft guidance addressing a variety of gene therapy issues. These cover a range of topics and have been promised by FDA. Another 2 guidance were also published this week. No guidance was published by the EMA. WHO published 1 document. The non-guidance collection included the usual sets from MHRA, EMA, [...]

FDA Sent These 4 Warning Letters for Food Companies | June 2018

We took a snapshot of the 4 warning letters the FDA sent to food companies last month. Food violations ranged from failing to label products (a lot!) to failing to train supervisors. From companies in California, New York, and more, here they are: LNZRO Pizza Empire, Inc, Syracuse, NY – 3 violations: Fails to conduct hazard analysis for products that [...]

By | 2018-07-16T17:40:23+00:00 July 16th, 2018|CGMP, FDA Warning Letters, Food, FSMA|

Week of July 1st 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 warning letters this week, including 1 to a finished pharma firm, 1 to an API manufacturer, and 1 to a compounding pharmacy. We cover these 3 below: DRUGS: Foshan Jinxiong Technology Co., Ltd. (Guangdong, China) received a warning letter on June 26th 2018 based on the outcome of an inspection ending August 18th 2017. The firm [...]

GMP Regulatory Newsletter: Summary Scan | Week of 7/1/18

Laws, Regulations, Guidance, and Concept Papers Just a few guidance documents and updates on non-guidance documents. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement: 3 warning letters. 1 warning letter in particular is a read for anyone interested in what FDA expects regarding identified [...]

See You At IFT

Next week we will be joining the 23,000 attendees and 1,200 other exhibitors at IFT in Chicago. We’ve made huge improvements to our platform specifically tailored to the food industry and will be sharing the latest updates. Be sure to stop by our booth to say hello and get your free supplier assessment. (RELATED: Shine a light on your [...]

Week of June 24th 2018 | FDA Sent These Warning Letters to Pharma Companies

This is a particularly spare week for warning letter publication. There is only 1 to an API manufacturer, and we cover it below. Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. DRUGS: Henan Lihua Pharmaceutical Co. Ltd (China) received [...]

Who Can See Form FDA 483s, and Where Do I Get Them?

Form FDA 483s are central to anyone’s FDA inspection preparation program. As the keeper of the world’s largest database of FDA 483s, we often get asked, “How do you get a hold of actual 483 reports and who else can see them?” This is where things get a little tricky. Theoretically, Form FDA 483s are public information and, thus, [...]

By | 2018-07-05T16:26:50+00:00 July 5th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Form FDA 483, Medical Devices|

GMP Regulatory Newsletter: Summary Scan | Week of 6/24/18

Laws, Regulations, Guidance, and Concept Papers: Guidance documents this week were from the FDA, EMA, and HPRA. Among the FDA ones are 2 programs where FDA will further pursue and investigate criteria for their Quality metrics program. The non-guidance documents include publications from MHRA, EMA, FDA, TGAA, and ICH.  Several are worth a serious read. To see the complete [...]

Week of June 17th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 15 warning letters this week -- many issued by the Center for Tobacco Products, and 3 issued for firms in the areas we cover. GLP STUDIES, BIMO: Benedict S. Kiao, MD, at the Oeyama-Moto Medical Group Foundation, Inc (West Covina, CA) received a warning letter dated May 21st 2018, based on the outcome of an inspection conducted [...]