Catch label errors before your next inspection
Inspack checks every label, container and insert against 503B requirements and your SOPs, across every site, in minutes.
01 / The problem
Label errors still show up in warning letters
Every label checked the same way, at every site
What we check
- Patient-specific and batch labels
- Container labels and outer packaging
- Inserts and directions for use
- Active and inactive ingredients
- BUD, lot and storage statements
- “Office use only” and “Not for resale”
Against what
- 503B labeling requirementsevery product
- Your label templates and SOPsturned into checks
- State pharmacy board rulesby state you ship to
Every issue comes with
- the rule behind it
- a suggested fix
- a full audit trail
02 / How it works
From label template to QA release
Add a label set
Upload the label, container and insert for one product. Pick your rules or use the ones we suggest.
- Batch labelMethylcobalamin 1,000 mcg/mL injectionAdded
- Container label10 mL multi-dose vialAdded
- InsertDirections for useAdded
See every finding
Missing statements and mismatches across documents, each with the rule behind it.
“Not for resale” missingFDCA 503B(a)(10) · labelIssue- Container strength differs from batch labelCross-document checkIssue
- BUD missing from container labelYour SOP · BUD ruleIssue
Release with a record
QA signs off before labels print. Every review is logged and ready for your next inspection.
03 / The difference
Label review, with and without Inspack
| Today | With Inspack |
|---|---|
| Labels checked by eye | Every product checked against the rules |
| Mismatches found after printing | Caught before labels print |
| Each site follows its own process | One ruleset across every site |
| New formulations wait for QA | First pass in minutes |
| Proof lives in email threads | One review record per product |
Get a free label check
Send us three label sets: label, container and insert. We return every finding with the rule behind it.
04 / FAQ
Compounded drug labeling, answered
Yes. 503B labels are checked against the statutory label requirements. For 503A, upload your label templates and SOPs, including your BUD rules, and Inspack turns them into checks.
Yes. Set your rules once and every site reviews against the same checks.
Yes. Check corrected labels before they print, and keep new formulations from repeating the same findings.
No. Inspack is the first pass, so QA and your pharmacist in charge only spend time on real findings. It doesn’t give legal advice.
No. Inspack reviews label content. It doesn’t assess CGMP, sterile or non-sterile compounding practices.
No. We review label content, not prescriptions or patient records.
05 / Resources
Latest on Inspack
Exploring AI, compliance, and packaging validation practices
Article ·
Pharma packaging compliance: 7 best practices for staying on top of industry standards
Discover 7 best practices for pharma packaging compliance. Learn how to manage labeling accuracy, safety features, and scalable workflows to avoid recalls.
Read more
Article ·
The latest FDA packaging requirements: key updates you should be aware of
An up-to-date overview of FDA packaging requirements, recent enforcement updates, and what brands must do to maintain FDA packaging compliance across regulated products.
Read more
Article ·
Pharmaceutical packaging requirements and patient safety: What’s the connection?
Pharmaceutical packaging requirements directly affect patient safety by preventing contamination, dosing errors, and misuse. Understanding how packaging compliance protects consumers helps brands maintain trust and meet regulatory standards.
Read more