Just Politics

[B402]

FDA over seas, Lol and ones who know right from wrong and do not put profits over patients. Evidence collected by FDA inspectors shows this is sorely lacking in overseas manufacturing facilities.

Automation and investment in upgrading facilities is an argument made to distract from the real issue, which was never about capacity, technology or training. It is all about profits, because quality comes at a price. There is a cost to destroying a batch of drugs that doesn’t meet release specifications, and no amount of third-party consultancy or employee retraining will address that issue.

While shiny new stainless steel reactors and automated processes may well be showcased for products made for Americans, the companies that tout them use dilapidated, pest-infested, unsanitary conditions to make medicines for consumption by patients in India and for export to other countries, especially those in Africa and Latin America.

U.S. law requires meticulous record keeping at all FDA-approved plants that make pharmaceutical products for the U.S. market. Not maintaining records is not an option. By covering up failed test results, companies were essentially covering up the sale of adulterated medicine to Americans. If these companies were to maintain accurate records of all the failed tests for products to be sold in the U.S., they would also be required to destroy or recall entire batches of medicine that had failed to pass tests conducted before their release. This would mean lost profits, and that is the simple reason behind the massive efforts these companies have invested in — like undisclosed quality control laboratories — to manipulate and fabricate data, even if it comes at the cost of compromising lives.

https://www.statnews.com/2019/07/22/indian-pharmaceutical-industry-drug-quality-charges/

We have much better control here, not to mention.....