§ QA

Quality & compliance

Your name goes on the bottle, so the record behind it has to hold up. Here is exactly what we test, what we keep, and what you receive.

§ QA-100

FDA registered establishment Registered for over-the-counter drug, dietary supplement, and cosmetic manufacturing

GMP certified Current good manufacturing practice

Florida Dept. of Agriculture Food permit, Division of Food Safety

DERM regulated facility Miami-Dade Department of Environmental Resources Management

Certificates available on request under NDA

§ QA-200

What happens to every batch

No batch skips a stage, and no stage is signed off from memory. Each one is recorded as it happens.

Incoming material control Every raw material and component arrives into quarantine. Nothing moves to production until identity is confirmed and the supplier's certificate is on file.

Master formula issue Production works from a written, version-controlled master formula and a batch record issued for that specific lot. No lot runs without one.

In-process checks Appearance, pH, viscosity, specific gravity, and fill weight are checked at set intervals while the batch runs, and recorded against the specification.

Line clearance Between products the line is cleared, cleaned, and verified so that no component or label from the previous run can carry over.

Finished goods testing The filled product is tested against its release specification. Microbiological and analytical work that needs outside capability goes to accredited third-party labs.

Release and retention Quality signs the release. A retained sample from every lot is held so that any future question can be answered against the actual product.

§ QA-300

What you receive with the shipment

Retailers, distributors, and auditors all ask for the same things. You should not have to chase your manufacturer for them.

Certificate of analysisRelease results against the agreed specification, per lot

Batch record summaryLot number, quantity produced, dates, and in-process results

Component traceabilityRaw material and packaging lots used in your batch

Retained sampleHeld at the facility for the product's shelf life

Stability dataWhere a study has been run to support your shelf-life claim

Racks of retained sample bottles held on the shelf — Fig. 03 — Retained samples, one per lot

§ QA-400

Regulatory support

Most of our clients are brand owners, not regulatory departments. We fill that gap rather than handing you a list of things to go and solve.

Establishment & product listingGuidance on FDA establishment registration and product listing obligations for your SKU

Label reviewDrug facts and supplement facts panel layout, net contents, and required statements reviewed before print

Claim reviewA read of your marketing claims against what the category and the formula will actually support

Audit responseDocumentation pulled and supplied when your retailer or a regulator asks

§ RFQ

Ask us for the paperwork first.

Good manufacturers are happy to be audited. Request our certificates and a sample batch record before you commit to anything.

Request documentation