Warning Letters – Brochure
So, you’ve received a warning letter… what do you do now?
It’s important to get a clear understanding of the message that the regulatory authority (FDA), is trying to send to your company.
It’s not just about the words, it’s more about what the intent of the observations listed is trying to convey. More often than not, the observations are illustrative of wider compliance concerns, so you need to look past just answering/addressing observational deficiencies. This is a trap that many fall into and it’s often a big mistake!
Presentation: Warning Letters, Consent Decrees and cGMP Compliance