[jeroen94704]

This is part of the standard FDA procedure. It starts with a formal warning letter (they send out many of those each year, for varying degrees of severity), and give the company a chance to address the non-conformities and violations. If a company fails to address the issues found, further action is taken, as evidenced by this bit from the end of the letter:

"Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts."

I've recently browsed through these warning letters for educational purposes (they're all publicly published on the FDA website), and this is by far the sternest letter I've seen.