SOPSync

Got an FDA Form 483 or Warning Letter citing missing, outdated or unfollowed written procedures? We write the SOPs from what your operators actually do.

Your operator does the task once while SOPSync records it. You get a step-by-step work instruction with annotated screenshots and a time for every step. Everything is processed on our own machines, not in the cloud. Fixed price, written intake, no sales call.

Response Pack

$1,500

5 SOPs for the cited processes, delivered in 5 business days, with one round of edits.

Full Remediation

$3,000

12 SOPs plus a training sign-off sheet, delivered in 10 business days.

Monthly Re-Check

$250/mo

We re-record changed procedures and flag drift, so you stay audit-ready.

We write the procedures and documentation. We do not file with the FDA for you, and we do not guarantee an inspection outcome. You review and approve every SOP before it is final.

See a sample SOP (PDF)

Send your 483 / request an invoice

Tell us which package you want and which processes were cited. We reply by email within one business day with scope and an invoice. Nothing is charged by this form. You can attach your 483 or Warning Letter in that reply, or email it to [email protected].

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