Quality & Compliance
Quality & Compliance
Every claim on this page traces to a real license number, a real regulation, or a real step in our own process, not a badge we bought. If any of it doesn’t check out, that’s worth knowing before you sign anything.
Every claim below traces to one real thing: a license number, a lab result, or a documented process step.
Licensing
Two licenses, both checkable.
Gotham Manufacturing Corp holds a Tier 2 Processor license (OCM-PROC-24-000200) and a Distributor license (OCM-DIST-25-000134) from New York’s Office of Cannabis Management, both verifiable directly on the state’s cannabis licensing dashboard. Our facility is at 55 Corbin Avenue, Bay Shore, NY, the address behind both licenses.
cGMP and 21 CFR 111
The dietary-supplement standard, not a shortcut.
We manufacture under 21 CFR 111, the federal dietary-supplement GMP framework, the same standard Gotham’s own CEO spent over 20 years operating under before entering cannabis. That means qualified personnel, controlled physical plant and equipment, documented production and process controls with a batch record for every run, a quality control function with real authority to approve or reject a batch, in-process and finished-product testing against real specifications, controlled packaging and labeling, and retained records. Not informal shortcuts that happen to produce a good batch most of the time.
METRC: Every Step Tracked
Not optional paperwork, every time.
New York runs its cannabis supply chain through METRC, and every requirement applies to us, every time, not as optional paperwork. Every package gets a unique METRC package tag before it leaves our facility. Every individual retail unit carries its own Retail Item ID before transfer to a distributor. Every transfer between licensees gets logged in METRC with a compliant manifest generated in the system itself, not written up after the fact. Inventory has to show a passed test result in METRC before it can transfer to a dispensary at all.
Pre-Production Sample Approval
You approve the real thing, not a spec sheet.
You approve a real, physical sample before we run full production, on everything we make except Flower Packaging (where it’s a usual practice, not a hard gate). Nothing scales up on your order until you’ve signed off on what it actually is, not a spec sheet describing what it should be.
Testing and Release
A failed result means it doesn’t ship.
Every batch gets tested before it ships, against the full range OCM requires: cannabinoid potency, heavy metals (lead, arsenic, cadmium, mercury), pesticides, mycotoxins, residual solvents (required on infused and extracted products), the full regulated microbial panel including hard pathogen-absence standards for Salmonella, STEC, and Aspergillus species, plus moisture content and water activity. A failed result on any one of them means the batch doesn’t ship, on the state’s standard, not just our own.
This isn’t hypothetical for us. In March 2026, a New York testing lab was found to have falsified Aspergillus and heavy metal results, triggering a mandatory statewide recall of over 50 lots. Gotham had used that lab, and moved to a different one as soon as we caught wind of a problem. When the mandatory quarantine and retest requirement hit, every product we’d had tested through them went back through testing again, this time at our new lab. All of it came back clean and was released from quarantine. That’s hold-and-release working under real pressure, not a line item in an audit checklist that’s never actually been tested.
Vape-specific checks go further: every cartridge, AIO, and disposable unit gets checked before packaging, not sampled. Leak detection, firing function (draw or button, whichever the device uses), and for AIO and Disposable specifically, battery-to-fill timing. A unit that fails any check doesn’t ship.
Label Compliance
Two labels, same-day printed.
Every product carries a two-label system: a primary label with your brand design, and a separate print-and-apply compliance label carrying the batch-specific numbers required under OCM Part 128, THC%, CBD%, TAC%, lot number, manufacture and expiration dates, solvents used, and the mandatory METRC RUID. We print and apply that second label in-house, the same day lab results land.
Third-Party Quality Audit
Independently audited, not self-assessed.
Gotham is audited by ASI against the Cannabis Safety & Quality (CSQ) cGMP Audit Requirements, a real independent certification standard, not a self-assessment. The standard covers fifteen distinct areas: a documented cannabis safety management system, processing controls, non-conforming goods handling, internal audits and pre-operational inspections, supplier approval, cleaning and sanitation, chemical controls, pest control, water and air quality, waste disposal, foreign matter controls, storage and distribution, facility and equipment design, maintenance and calibration, hygiene practices, and security.
Scoring is percentage-based, starting at 100% with deductions for every finding: minor non-conformances cost 1%, major non-conformances cost 5%, and a single critical non-conformance, a deficiency that could cause serious illness, death, or any falsified safety record, fails the audit outright regardless of everything else. A score of 70% or higher earns certification; anything below does not.
Gotham scored 95 out of 100.
Current CSQ certificate is valid through mid-December 2026, on CSQ’s standard one-year cycle requiring annual re-certification, not a one-time badge.
Quality & Compliance FAQ
Are your licenses actually verifiable, or do I just have to take your word for it?
Verifiable directly on New York’s state cannabis licensing dashboard: Processor OCM-PROC-24-000200, Distributor OCM-DIST-25-000134.
Were you affected by the 2026 New York lab fraud recall?
Yes. We’d used that lab before the fraud came out and had already moved to a different one when we caught wind of a problem. Every product we’d had tested through them went through mandatory quarantine and retesting at our new lab. All of it came back clean and was released. That’s the hold-and-release system working the way it’s supposed to under real pressure, not just on paper.
What happens if a batch fails testing?
It doesn’t ship. Every batch is tested before release regardless of who supplied the inputs, and that’s a hard gate, not a formality.
Do you track everything in METRC, or just what’s required?
Every package tag, every retail item ID, every transfer manifest, every test-pass status, all in METRC, all the time. Not treated as optional paperwork.
What’s the actual source of your “95/100 Quality Score” claim?
Audited by ASI against the Cannabis Safety & Quality (CSQ) cGMP Audit Requirements, a real independent standard with percentage-based scoring across fifteen compliance areas. Gotham scored 95 out of 100, confirmed directly by Mike, who walked the audit personally.
Ready to talk production?
Tell us what you’re building, or spec it out yourself first.
