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The FDA posted 4 warning letters this week — 2 of which were GMP letters to drug firms. One firm manufactures APIs and the other manufactures finished pharmaceuticals. We address both below. DRUGS: Kyowa Hakko Bio Co., Ltd (Yamaguchi, Japan) received a warning letter on August 10th 2018 based on the outcome of an inspection […]

Continued from Part 1… CHANGES, REVISIONS, and DELETIONS from the 2015 VERSION: “ADDITIONS” are those sections that are new in 2018.“REVISIONS” generally denote expansion of sections between the 2 versions.“DELETED” identifies sections in the 2015 guidance that did not carry over to the 2018 version. CONCLUSION: The additional details and new topics identified in this […]

A very busy week on the warning letter front! Six warning letters to API/pharma firms and 1 to a GLP firm for non-clinical studies. We cover all below: GLP: North American Science Associated (NMSA) (Minneapolis, MN) received a warning letter on March 23rd, 2018 based on the outcome of a BIMO inspection ending November 17th, […]

MHRA published a revision to their 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016. The MHRA Inspectorate blog says that the health authority received over 1300 comments during the consultation process. The revision was a coordinated effort among the GCP, GDP, GLP, GMP, and GPvP inspection groups reflecting a broad […]

In the past 2 weeks we added the following 483s to our database of 27,500+ 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=18] Like This & Want More? Sign up to get free […]

This week the FDA published 4 warning letters (3 to seafood companies and 1 to an API manufacturer – Les Produits Chimiques B.G.R. Inc). We cover the latter below. DRUGS: Les Produits Chimiques B.G.R. Inc (Montreal, Canada) received a warning letter on July 24th, 2018 based on the outcome of an inspection ending September 27th, 2017. […]

We took a snapshot of the 6 warning letters the FDA sent to food companies last month. Food violations ranged from failing to implement sanitation preventive controls to failingto have an HACCP plan. From companies in Texas, Puerto Rico, and more, here they are: Roorda Dairy, LLC,Paullina, IA – violations include but are not limited […]

The FDA posted 9 warning letters this week including 1 to a device manufacturer, 1 each to an API manufacturer and compounding pharmacy, and, finally, 2 to finished dosage form manufacturers. DEVICES: Anigan, Inc. (San Ramon, CA) received a warning letter on July 25th 2018, based on the outcome of an inspection ending April 19th […]

Laws, Regulations, Guidance, and Concept Papers Another collection of FDA User Fee Rates for FY2019 was released (including those for drugs, outsourcing facilities, and biosimilars).EMA published several items including a broad draft guideline that covers gene therapy products and the CAR-T family of products.WHO published 3 guidance for consultation.HPRA, Health Canada, and PIC/S each published […]

A really slow week — 1 letter to a compounding pharmacy and 1 to a firm for misbranded unapproved drug marketing. We cover the compounding pharmacy letter consistent with past practices. COMPOUNDING PHARMACY: Gipsco Investment Corp dba Lee Silsby Compounding Pharmacy (Cleveland Heights, OH) received a warning letter on July 10th 2018 based on the […]