DOes the FDA actually do anything or is it like "law enforcement" that shows up to your house after your family has been murdered and just write reports about it?
DOes the FDA actually do anything or is it like "law enforcement" that shows up to your house after your family has been murdered and just write reports about it?
The FDA has two main functions.
1.) Write regulations that manufactures are legally compelled to comply with in order to receive permission to sell products which the FDA has jurisdiction over
2.) Conduct periodic inspections of licensed manufactures to assess compliance to regulations
Depending on the inspection findings, the FDA has the legal authority to order a manufacturer to correct non-compliant processes and practices, and in more extreme circumstances, prohibit the manufacturer from selling product in the US and even arrest and press legal charges against company officers for breech of legal regulations (ie laws.)
483's (the original Inspection Report findings of non-compliance) are serious, but not uncommon. They list the non-conformances and the company has a limited amount of time to respond (eg 30 days) and implement corrective actions. It is up to the company to propose and commit to the CA's. The FDA
will follow up and assess the proposals and their implementation.
A Warning Letter is far more serious. It comes after a history of non-compliances (483's) or very serious non-compliances, or failure to properly correct deficiencies. Its a "get your shit together fast or we're coming to shut you down" letter.
Failure to implement lasting corrective action for these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
That's where this company is at. Deep F'ing shit, and if you know how to read this letter, its unlikely they will be able to correct all their issues in time. Their deficiencies are deep and serious and they seem incompetent to correct them. They look headed for a Consent Decree and may lose their licence. This has destroyed companies before, and you can bet there are heads rolling at the firm (there should be..)