It is important to harness this enthusiasm and create parallel work streams. Listen, engage, and respond to concerns and comments, as your staff may offer useful information for your response to FDA.
Outline how each deficiency will be corrected, and when, rather than how the deficiency came to be. Contrast them with what I believe are more measured and effective responses. There is no regulatory requirement to respond to a A quality remediation project can last from a few months to over a year, pulling resources from development or ongoing business operations.
Be prepared to defend the duration of the retrospective review as well as any sampling plans that are used to analyze the data as part of the response. Every observation should have a thorough root cause analysis performed and, if necessary, one or more corrective and preventive actions CAPAs identified, along with a CAPA reference.
Like all good scientific writing, a good cover letter should state up-front what you are going to tell the agency. I prefer a table that looks like the example shown below.
FDA requires a response to most compliance notices within 15 business days. Better response: The freeze-drier is on our break-down maintenance schedule.
You need to understand the root cause of the issue to truly understand its impact on all products. You need to respond aggressively to FDA s with corrective actions, and submit your response early.
For example, you do not have, as part of the storage condition, any documentation that stability samples are maintained at the designated temperature [21 CFR