FACILITY / AMHERST, NY 14228 | EIN 16-1274257 | DESK Mon-Fri, 9am-5pm ET | contact@onybiotechinc.com
ONY BIOTECH INC Nutraceutical formulation & batch testing
[ 01 ]  The company

ONY BIOTECH INC

A privately held biotechnology company on the Amherst research corridor, north of Buffalo. We formulate nutraceuticals, run them through a documented production and testing cycle, and now sell one finished consumer product direct.

How the company is set up.

ONY BIOTECH INC was organised as a New York corporation to do one narrow thing well: take a written composition sheet and turn it into a finished, tested, traceable bottle. For most of its life the work has been contract formulation for other labels, which means our name appears on almost nothing we make. NerveAura is the first formulation we have taken all the way to the consumer ourselves.

The team is small — formulation, production, quality and a correspondence desk. There is no sales floor and no call centre, which is why every enquiry on this site is handled in writing by email at contact@onybiotechinc.com during Mon-Fri, 9am-5pm ET. The person who answers a documentation request can walk to the shelf the record is on.

Direct sale changes nothing about how we talk about the product. We publish composition, quantities, sourcing and test scope. We do not publish outcomes, testimonials or comparisons, because a laboratory that measures identity and purity is not a laboratory that has measured effect. Confusing the two is the single most common failure in this industry and we would rather be dull than commit it.

At a glance

Founded as
ONY BIOTECH INC
Structure
New York corporation
Function
Formulation, blending, encapsulation, batch testing
Consumer products
One (NerveAura)
Channels
Direct from onybiotechinc.com
Correspondence
Email only, Mon-Fri, 9am-5pm ET

We are a manufacturer and a seller. We are not a clinic, we do not employ clinicians, and we cannot advise anyone on their health.

[ 02 ]  The facility

1576 Sweet Home Road, Amherst.

The building sits on the Sweet Home Road corridor beside the university's north campus, an area given over to small laboratory and light-manufacturing tenants. Our footprint is modest and purpose-built rather than large: six controlled areas, each with one job and one set of rules for leaving it.

Exterior of a small modern biotechnology building in a suburban research park under overcast daylight.
[ FIG 01 ]The research-park building the laboratory occupies. Deliveries and returns are received at the rear; there is no retail counter and no public entrance.
Rooms and their controls
AreaPurposeControls
QuarantineIncoming raw material holdSegregated racking, status labelling, no release without paperwork
Identity benchConfirmation of incoming materialHPTLC and FTIR, reference standards under lock
Blend roomWeighing and blendingCalibrated balances, line clearance between lots, single-lot occupancy
EncapsulationCapsule filling and bottlingFill-weight checks at fixed intervals, in-line rejection
Finished holdLot quarantine pending resultsPhysically separated, released only on written disposition
RecordsBatch record and retain archiveRetained per lot, retrievable by lot code

Balances are calibrated on a scheduled interval against traceable weights, and the calibration record travels with the balance rather than living in a separate binder. Temperature and humidity in the blend, encapsulation and finished-hold areas are logged; excursions are written up against any lot that was in the room at the time.

[ 03 ]  The quality system

Written down, then followed.

Six documents carry the whole system. None of them is remarkable; the discipline is in producing them every time rather than in what they say.

A / SPECIFICATIONS

Ingredient specification

Every ingredient has a written specification covering identity, form, grade and the quantity per serving. Nothing enters a blend that is not on the sheet, and the sheet is versioned so an old lot can be read against the specification that was current when it was made.

B / SUPPLIER FILE

Approved supplier file

Suppliers are approved on file and must ship with a certificate of analysis per lot. Certificates are reviewed against our specification before the material leaves quarantine. A supplier that ships out of specification twice comes off the file.

C / BATCH RECORD

Batch record

Each lot carries a batch record: raw material lot numbers, weights, equipment used, operators, in-process checks, any deviation raised, and the final disposition signature. It is completed as the work happens, not written up afterwards.

D / RETAINS

Retain samples

A sealed retain sample is kept from every lot for the life of the best-before date plus one year, so any bottle in the field can be compared against material we still hold rather than against a memory of it.

E / TESTING

Independent testing

Heavy metals and microbial limits are run by an independent contract laboratory under its own report reference. Results are filed against the lot code and are sent to any customer who asks, quoting the code on their bottle.

F / COMPLAINTS

Complaints and deviations

Written complaints are logged with a reference, investigated against the batch record and the retain, and answered by email with what was found. A complaint that implicates the lot rather than the individual bottle triggers a hold on remaining stock of that lot.

If something is wrong with a lot

  1. Hold. Remaining stock of the lot is moved back to the finished hold and marked unsellable the same day.
  2. Investigate. The batch record, the raw material certificates and the retain sample are examined together, and the finding is written up against the lot.
  3. Notify. We can identify every order that shipped from a given lot and write to those customers by email with the lot code and what was found.
  4. Resolve. A refund or replacement in that situation is not conditional on the 180-day return window.

What the system does not do

Quality control confirms what is in the bottle, that it is clean, and that it is correctly counted. It does not establish that the contents do anything, and it is not evidence of a health effect. We keep saying this because a page full of instruments and acronyms is exactly the kind of page where a reader supplies the claim we did not make.

Statements on this site have not been evaluated by the Food and Drug Administration, and NerveAura is not intended to diagnose, treat, cure or prevent any disease. Naming an ingredient, a test or a method here is not a claim about what any of them does for a person.

[ 04 ]  Business record

Who you are buying from.

Legal name
ONY BIOTECH INC
Trading as
ONY BIOTECH INC
EIN
16-1274257
Registered address
1576 Sweet Home Road, Amherst, NY 14228, US
Governing state
New York
Website
onybiotechinc.com
Desk hours
Mon-Fri, 9am-5pm ET
Sales channel
Direct only; no marketplace, reseller or subscription billing
Returns window
180 days from delivery

Document requests

Certificates of analysis, ingredient specifications and supplier attestations are released against a lot code. Send the code printed on the base of your bottle to contact@onybiotechinc.com, or use the enquiry form. The desk normally returns the file within one business day.

Text messages

Our SMS programme is marketing only and entirely optional. Consent is not a condition of any purchase, message frequency varies; no more than 4 per month, and replying STOP cancels it. Message and data rates may apply. Order and shipping information always comes by email. No mobile information is shared with third parties or affiliates for marketing or promotional purposes.

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Policies

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