Credentials
The complete manufacturing credential chain for SkinTech / EffectsRx, LLC — from facility certification to product-level testing documentation.
Island Kinetics, Inc. dba CoValence Laboratories
All SkinTech formula production is conducted exclusively at CoValence Laboratories in Chandler, Arizona. CoValence is an ISO 22716-certified, FDA-registered contract cosmetic and OTC pharmaceutical manufacturer operating under US cGMP standards.
The Quality Agreement between EffectsRx, LLC and CoValence Laboratories, executed April 17, 2017, governs all aspects of the manufacturing relationship including raw material qualification, batch testing, CoA issuance, complaint handling, and recall protocols.
ISO 22716 — Cosmetics Good Manufacturing Practice
ISO 22716 is the international standard for Good Manufacturing Practices in cosmetic production. It defines requirements for the production, control, storage, and shipment of cosmetic products — covering personnel, premises, equipment, raw materials, production, finished products, quality control, waste management, and subcontracting.
ISO 22716 certification is voluntary in the US but is the recognized international benchmark for serious cosmetic manufacturing. It requires a successful third-party audit of the manufacturing facility against the full standard. CoValence's certification was issued following audit on October 16, 2017, and was valid through November 2018 with ongoing renewal.
- ■ All materials undergo strictest Quality Control per ISO 22716 standard
- ■ Manufacturing to Cosmetic cGMP as outlined in US Code of Federal Regulations, CFR Title 21, Section 700
- ■ All batches tested at multiple stages: correct compounding, packaging, and labeling verification
- ■ FDA-registered as authorized to produce OTC registered products, reviewed during FDA audits
What the Quality Agreement covers.
The Quality Agreement between EffectsRx, LLC and CoValence Laboratories (executed April 17, 2017) formally allocates quality responsibilities between manufacturer and client. Key provisions:
Material qualification
CoValence is responsible for testing and release of all raw materials. Client-supplied actives (including the pharmaceutical-grade PBN spin trap compound) are held to the same testing requirements as CoValence-stocked materials, including micro testing.
Batch testing & release
CoValence is responsible for testing and release of all finished goods. Products are tested at multiple production stages. Batch records are maintained. Certificates of Analysis (CoA) are issued on request for any produced batch.
Component qualification
10% incoming inspection of approved packaging components on initial receipt. Full quality and quantity check of all packaging during the fill process. Compatibility evaluated through stability testing in actual marketed packaging.
Facility standards
CoValence ensures that facilities, equipment, personnel, training, procedures, and products remain compliant with the applicable quality programs. Audits permitted with 7 days' notice under a current NDA.
Change notifications
CoValence reviews and submits all change control documentation when changes affect form, function, or labeling of a product. EffectsRx, LLC is notified of any such change.
Complaints & recalls
All complaints recorded and investigated per CoValence's Customer Complaint SOPs. Recall decisions are made jointly, with both parties involved in end-user notification and disposition of returned or unused product.
Testing conducted on SkinTech formulas.
Documentation available on request
Certificates of Analysis, full stability test reports, RIPT results, the Quality Agreement, ISO 22716 certificate, and cGMP Quality Management Certificate are available to authorized parties on request. Contact EffectsRx, LLC directly.
EffectsRx, LLC
EffectsRx, LLC is the legal entity under which all SkinTech formulas were developed, and under which the CoValence quality and manufacturing agreements are held. Lori Howard is the founding member and registered agent.
All downstream brands in the SkinTech family license or operate under the EffectsRx, LLC formulation platform. The intellectual property in the formulas — the concentration ratios, ingredient interactions, and the Spin Trap System™ as applied to this formula class — remains with EffectsRx, LLC.