FDA inspection tomorrow.
Are your batch records complete, searchable, and ready in 30 seconds?
1,578 FDA observations on dietary supplement manufacturers in 2024 — up 46% in one year. The top three findings: incomplete batch records, unverified supplier COAs, insufficient component identity testing. All three are directly automatable. We automate them. Your QM signs off.
No sales call. Send us 3 supplier COA PDFs → automated pass/flag verification → delivered within 48 hours.
No sales call.
Describe your workflow →
response within 24 hours.
Serving compliance-heavy operations in:
Why cGMP Manufacturers Use FDAReady
We automate the documentation. Your QM keeps the authority.
Four weeks from "interested" to "this is working." A CMO running 50 batches per month that automates COA verification and BPR pre-population recovers 75+ hours every month — enough QA bandwidth to onboard 10 new brand clients without adding headcount.
Proof before payment.
Send us 3 supplier COA PDFs and the corresponding batch record. We return the automated verification — pass/flag results — within 48 hours. You compare it to what you would have caught manually. We invoice only when it works on your actual documents.
We don't build dashboards.
COA-against-MMR verification engines. BPR pre-population from your Master Manufacturing Record. Lot-indexed dossier search for FDA inspections. Automated COA generation for your brand clients. The difference shows in week two — and on your next Form 483.
Your formulas never leave your facility.
Every automation runs in your environment or a dedicated isolated tenant. We sign NDA + Data Processing Agreement before touching any batch record or supplier COA. Your production data never touches shared infrastructure. No exceptions.
No sales call. Describe your workflow → response within 24 hours → free analysis sent by email.
No sales call.
Describe your workflow →
response within 24 hours.
Who We Serve
We work with nutraceutical contract manufacturers. One standard: the automation handles the documents. Your QM handles the decisions.
Batch records by lot. Supplier COAs by ingredient. FDA dossiers by inspection date. One CMO managing compliance for 20 to 60 brand clients. Select a workflow below to see what we automate.
The Real Cost
75 hours of QA documentation every month. That's not an efficiency problem. That's a growth ceiling.
Your Quality Manager — the one who knows 21 CFR Part 111 backwards — is spending Tuesday morning comparing supplier COA values to MMR specs by hand. On the 40th PDF of the month. Human attention flags long before the stack does. The FDA has seen this: component identity testing violations jumped from zero in 2023 to 66 observations in 2024. Your QM's name is on every one of those records.
Your Quality Manager — the one who knows 21 CFR Part 111 backwards — is spending Tuesday morning comparing supplier COA values to MMR specs by hand. On the 40th PDF of the month. Human attention flags long before the stack does. The FDA has seen this: component identity testing violations jumped from zero in 2023 to 66 observations in 2024. Your QM's name is on every one of those records.
No sales call. Describe your workflow → response within 24 hours → free analysis sent by email.
No sales call.
Describe your workflow →
response within 24 hours.
What We Build
Eight automatable workflows. One QA operation that scales without adding headcount.
From supplier COA ingestion to FDA-ready lot dossier — including BPR pre-population that runs the moment a production order is created. Every automation is monitored, documented, and maintained. If it breaks on a Tuesday at 11pm, we know before your QA team does.
Supplier COA Verification
Every supplier COA compared against your MMR specifications automatically — identity, purity, heavy metals, microbiology, moisture. Result in 8 seconds: pass or flag. Your QA manager sees exceptions, not every document. No more 4-hour PDF comparison sessions on Monday morning.
Supplier COA Verification
Every supplier COA compared against your MMR specifications automatically — identity, purity, heavy metals, microbiology, moisture. Result in 8 seconds: pass or flag. Your QA manager sees exceptions, not every document. No more 4-hour PDF comparison sessions on Monday morning.
Lot Dossier Search
Index every batch record, supplier COA, in-process check, and deviation report — searchable by lot number, ingredient, or date. When FDA walks in, your complete dossier is ready before they finish their opening statement.
Lot Dossier Search
Index every batch record, supplier COA, in-process check, and deviation report — searchable by lot number, ingredient, or date. When FDA walks in, your complete dossier is ready before they finish their opening statement.
BPR Pre-Population & COA Generation
Trigger
Prompts
Send Email
Production order triggers automatic pre-population of the Batch Production Record from your MMR. Completed-product COA assembled automatically from lab results. Your QM verifies and signs. They don't build from scratch — every batch, every week.
BPR Pre-Population & COA Generation
Trigger
Prompts
Send Email
Production order triggers automatic pre-population of the Batch Production Record from your MMR. Completed-product COA assembled automatically from lab results. Your QM verifies and signs. They don't build from scratch — every batch, every week.
n8n
n8n
Claude AI (Anthropic)
Claude AI (Anthropic)
Python
Python
AWS Textract
AWS Textract
Vector Indexing
Vector Indexing
21 CFR Part 111
21 CFR Part 111
PDF Generation
PDF Generation
NDA on Request
NDA on Request
About Sumit Ops
A small firm. By design.
A small firm. By design.
FDAreadyai is not a 200-person agency with junior contractors on your account. We are a specialized automation firm working with a limited number of cGMP clients at any time — enough to give each engagement the attention it requires. Every automation is built and maintained by the same people who assessed your documentation in week one. We are based in Wyoming, USA. We work with nutraceutical contract manufacturers across the United States.
FDAreadyai is not a 200-person agency with junior contractors on your account. We are a specialized automation firm working with a limited number of cGMP clients at any time — enough to give each engagement the attention it requires. Every automation is built and maintained by the same people who assessed your documentation in week one. We are based in Wyoming, USA. We work with nutraceutical contract manufacturers across the United States.
Clément
Automation & Systems · Founder
Automation &
Systems · Founder
Joël
Outreach & Client Success · Founder
Outreach & Client
Success · Founder
Common Questions
The questions worth asking before you share a single COA.
Does this require access to our ERP or production systems?
No. For the proof of concept, you upload 3 PDF files to a shared Google Drive folder you create and control. You can revoke access at any time. We never touch your ERP or production systems. If you want deeper integration later, we deploy n8n inside your own network — your data never leaves your infrastructure.
Who is responsible if the system makes a verification error?
Is this compatible with 21 CFR Part 11?
What about our proprietary formulas and intellectual property?
How long before we see real results?
Is my batch record and production data confidential?
Does this require access to our ERP or production systems?
No. For the proof of concept, you upload 3 PDF files to a shared Google Drive folder you create and control. You can revoke access at any time. We never touch your ERP or production systems. If you want deeper integration later, we deploy n8n inside your own network — your data never leaves your infrastructure.