FDA 483 says your procedures are missing? Get the SOPs written in 5 business days.
A 483 observation about written procedures usually means one of three things: the SOP does not exist, it is out of date, or nobody follows it. We write the SOPs from what your operators actually do, so the document matches the floor.
Why not just buy quality software?
Small manufacturers tell us the electronic quality systems are priced for big companies. Public discussions list MasterControl at around $25,000 a year and Greenlight Guru at around $600 per user per month. Software also does not write your procedures; someone still has to. If you need the procedures fixed now, this is the cheaper first step.
What you get
- 5 SOPs for the processes your 483 cites, step by step, with annotated screenshots and a time for every step.
- Built from a recording of your own operator doing the task once.
- One round of edits. You review and approve every SOP before it is final.
- Everything is processed on our own machines, not in the cloud.
Price and timing
$1,500 flat for 5 SOPs, delivered within 5 business days. Need more? 12 SOPs plus a training sign-off sheet is $3,000 in 10 business days. Written intake, no sales call.
Pay $1,500 securely with Stripe
What this is not
We write procedures and documentation. We do not write or file your response to the FDA, we are not a law firm or a regulatory consultant, and we cannot promise how the FDA will view your response. Mind your response deadline: send us the 483 early.
Tell us what was cited
Paste the observation text. We reply by email within one business day with a scope and a start date. Nothing is charged by this form.