It is rare when a journalist reports on the GMP side of the industry. Most reporting tends to be pretty shallow, and only when a major crisis happens, such as the baby food manufacturing failures. So I love it when a journalist takes the time to understand our field and write a detailed piece. Katherine Eban, who wrote the insightful Bottle of Lies, which I am known to gift copies of, being a great example of a journalist can creditably speak our language and than translate it to the general public.

Patricia Callahan is another journalist I follow, because she writes stories like “The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems” about Glenmark, that demonstrates a basic understanding of the issues and is written for a non-GMP professional reader.

The article stresses the ongoing crisis in that the FDA does not have enough inspectors, a crisis that keeps getting worse under the current administration.

The Form 483 that is linked should frighten anyone, as it has 3 pages of redacted batches that were shipped to the US.

I share the frustration and concern that Form 483s are not transparent, and that the FDA does not follow the same principle of the average health inspector for local restaurants where I see the grade when I walk in. It is pretty difficult to figure out where a medicine is made, and failing access to some expensive services, can be a real pain to figure out the status of any given manufacturing site.

The Form 483 for Glenmark is, unfortunately, all too common for an Indian generics manufacturing site. Poor validation, no real cleaning, lack of investigations – these are all very serious, and unfortunately recurring.

I am very concerned that the woes of Indian manufacturing sites (and Chinese) will just get worse as the FDA is torn apart by a bunch of authoritarian ideologues who think sunshine and bleach are cure-alls.