Resources

NOTE: THIS POST IS OUT OF DATE AND THIS IS A LEGACY PLATFORM THAT IS NO LONGER IN USE. When the FDA notifies you of an upcoming inspection, sometimes you only have minutes to prepare. You need information, and you need it fast. Most companies start with a Google search or call their friends and […]

Laws, Regulations, Guidance, and Concept Papers This has been an unusually slow summer week5 documents published by FDA — 3 of which address user fees for FY2019 re: generic drugs, devices, and food re-inspections1 from EMA2 each from WHO and TGANon-guidance publications were issued by FDA, EMA, MHRA, ICH, and HPRA. Enforcement: Very slow with […]

FDA posted 6 warning letters this week. Two were issued to firms manufacturing finished pharmaceuticals. We continue to include the follow-up actions that FDA identified for the firm. Both are addressed below. DRUGS: bB BioCHem Laboratories Inc (Santa Ana, CA) received a warning letter on July 3rd, 2018 based on the outcome of an inspection […]

Laws, Regulations, Guidance, and Concept Papers Among guidance documents this week are 5 from FDA4 from EMA1 each from Health Canada, HPRA, and IMDRF2 from EMA/EC address gene therapyNon-guidance documents include the usual collection from MHRA, FDA, and EMA.Included here are expansion and renewal of the EU and Japan Mutual Recognition Agreement and a Biosimilar […]

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. [supsystic-tables id=15] Like This & Want More? Sign up to get free […]

Zuhai United Laboratories Co. Ltd. (Guangdong, China) received a warning letter on June 27th, 2018 based on the outcome of an inspection ending September 15th, 2017. FDA suggests they employ consultant(s) to assist them in coming into GMP compliance in their manufacturing of APIs. Deficiencies include but are not limited to:The firm failed to adequately […]

Laws, Regulations, Guidance, and Concept Papers FDA published 6 draft guidance addressing a variety of gene therapy issues.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, […]

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 […]

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 […]

Laws, Regulations, Guidance, and Concept Papers Just a few guidance documents and updates on non-guidance documents. Enforcement: 3 warning letters.1 warning letter in particular is a read for anyone interested in what FDA expects regarding identified errors in non-validated Excel spreadsheets.A limited number of recalls and import alerts this week.A slow summer with the US […]