Resources

Enforcement in terms of warning letter posting was busy this week. Among those issued were four that were sent to homeopathic drug product manufacturers, continuing a focus evident over the past two years (you can find the FDA press release here). Lachman Consultants released their perspective last week. In addition, there were another two to drug product […]

FDA posted 9 warning letters this week. This included two to pharmaceutical firms and two to compounding facilities. We cover these four below. The FDA has not yet published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a couple weeks ago. DRUGS | Mariposa Labs LLC Mariposa Labs LLC (Boise, ID) received a warning […]

Recently, the CDER warning letter issuance skyrocketed from 70 in FY2014 to 128 in FY2018, an increase of 83%. What types of firms are taking the heat? And where are they located? Here we answer these questions and more with a review of CDER warning letter trends in regard to facility type, including: Year-over-year analysis […]

We cover four warning letters this week including one for a human drug and three to device manufacturers, two of which are manufacturers of breast implants that failed to conduct post-approval studies. DEVICE | TEI Biosciences Inc. TEI Biosciences Inc. (Plainsboro, NJ) received a warning letter on March 6, 2019 based on the outcome of […]

Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing. Lupin announced that they received a warning letter, but it has not been posted by the FDA yet. […]

This series focuses on FDA enforcement surrounding drug GMP warning letters issued in FY2018. In parts one and two, we covered: Drug GMP warning letter trends since FY2013 Warning letters outside the U.S Enforcement of over-the-counter (OTC) and contract manufacturers/laboratories Import alerts associated with warning letters Data integrity deficiencies Here we look at the interval […]

This week there were a handful of warning letters issued to drug manufacturers. FDA continues an unrelenting focus on over-the-counter (OTC) (including cosmetics and sunscreen) and contract manufacturers. DRUGS | Becton Dickinson Medical Systems FDA published a close-out letter to Becton Dickinson Medical Systems regarding a warning letter the firm received on September 14, 2018. DRUGS […]

The theme of this year’s International Women’s Day is #BalanceforBetter. The campaign aims to reinforce the need for gender-balanced organizations and communities. At Redica Systems, we’re proud to say that 100%of our industry experts are women. We’re fortunate to have their expertise and experience on the team to help us develop and improve our platform, […]

This week we cover four warning letters: one to a device firm, two to drug manufacturers, and one to a cosmetics contract manufacturer. The two drug warning letters were issued to firms that manufacture OTC products, continuing FDA’s focus on this market segment. DEVICE:  Total Thermal Imaging, Inc (La Mesa, CA) received a warning letter […]

This week enforcement was busy with a GLP warning letter, warning letters to an API manufacturer and a pharmaceutical firm, a couple of compounding pharmacies, and a device firm. PRECLINICAL GLP: American Preclinical Services (Minneapolis, MN) received a warning letter on February 12, 2019 based on the outcome of an inspection ending April 13, 2018. […]