Cylinder receiving & lot documentation
Supplier license on file, delivery lot numbers logged, certificate of analysis retained, and every cylinder matched to a serial and requalification date at receipt.
FDA's medical-gas rule, 21 CFR Part 213, took effect December 18, 2025. If you fill your own oxygen cylinders, your fill records, purity tests, and training file now have to meet pharmaceutical-grade rules. It is a paperwork problem, and it is fixable this month.
One flat monthly retainer, written on the price sheet you get at the free station gap review. The squad keeps running calls; we keep the file inspection-ready.
| Included | What you get |
|---|---|
| Fill-station documentation program | Part 213 SOPs, quality-unit designation, lot logs, purity and odor records, training file, complaint and recall procedure |
| Cylinder tracking | Every O2 cylinder by serial, DOT spec, and requalification date, with out-of-date units flagged before they go on a rig |
| Rig and station extinguishers | Inspected, tagged, current (on permit issuance; documented and coordinated today) |
| AED program | Pads, batteries, and training records managed before they expire |
| SCBA and breathing air (fire departments) | Hydro cycles tracked, NFPA 1989 quarterly sampling calendar and lab records filed |
| Annual station audit | We walk it before an inspector does, with a written gap list |
| Terms | Flat monthly retainer from the written price sheet · 12-month term that does not auto-renew · cancel with 30 days' notice · records belong to the agency |
"I run calls in this county. I know what a Saturday night looks like, and I know nobody volunteers to do lot-log paperwork. That is exactly why I built this."
Founder, Safety City Compliance · NJ EMT
Every cylinder that enters a healthcare facility is a prescription drug in a DOT-regulated container, stored under NFPA 99 rules the fire official checks and dispensed under pharmacy rules the surveyor checks. We document the whole chain so both surveys close clean.
Supplier license on file, delivery lot numbers logged, certificate of analysis retained, and every cylinder matched to a serial and requalification date at receipt.
Full and empty segregation, quantity limits per smoke compartment, securing, signage, and the storage-room requirements surveyors cite most often, walked and photographed on a schedule.
Vendor inspection reports for bulk oxygen and manifold systems reviewed for open items, filed with the Environment of Care documentation, and tracked to the next due date.
Emergency oxygen supply connection tested and documented, reserve quantities verified, and the plan the Life Safety surveyor asks to see.
Type C occupancies are inspected four times a year. We pre-walk each one with a written checklist so the bureau's visit confirms what your file already shows.
Fire prevention bureau, CMS Life Safety, and the pharmacy survey read the same site file, organized the way each of them reads it.
Available now: the documentation and cylinder-tracking program above, and coordination with your existing filler or distributor so deliveries, lots, and requalification dates land in your file.
On the roadmap: medical oxygen cylinder exchange and, later, filling under our own FDA establishment registration, 21 CFR Part 213 quality system, DOT requalifier registration, and New Jersey wholesale drug distributor license. Each line is announced only when its registration issues. We will never sell you a cylinder we are not licensed to fill.
See the full licensing roadmap →Thirty minutes at your station or facility. We show you in writing exactly where your records stand against Part 213, the DOT cylinder rules, and NFPA 99. Want to fix it yourself with that list? Do it. The list is yours either way.