Laws, Regulations, Guidance, and Concept Papers

The week of February 11, 2018 was slow in the publication of guidance documents.

The FDA published three, and the EMA did not publish any in the areas we follow. Health Canada and HPRA each published one item. There were also non-guidance documents and information published by EMA, MHRA, and FDA.


Now, onto enforcement!

There was one warning letter issued to a device firm and four warning letters issued to drug firms. All five firms are located outside the US.

Recently, big-pharma has been an infrequent recipient of FDA warning letters, but this week we see a particularly harsh one issued to Bayer AG. The warning letter addresses issues of aseptic processing, data integrity, and demonstrated product cross-contamination. Justin Boyd was the single investigator for this inspection. The form-483 includes other items associated with data integrity and are worth reading. Remediation of the deficiencies will not happen quickly nor will it be inexpensive.

The FDA also released a form-483 regarding an October 2017 inspection of Hospira’s (Pfizer) site in McPherson Kansas. This site was the subject of a warning letter issued to Pfizer’s CEO in February of 2017. The 2017 inspection identified several observations that the FDA identified in previous inspections. The FDA database classifies the inspection as VAI.

Lastly, two drug firms were placed on import alert for refusing an FDA inspection. Drug recalls the week of February 11, 2018 included all classes as well as several that the FDA has not yet classified.