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Read MoreQuality, and Regulatory Compliance at PureTek
PureTek maintains the highest standards of compliance, which makes us the perfect contract manufacturer for all of your personal care, supplement, and prescription & OTC drug products. As a drug-licensed facility, we operate under FDA Part 211 and we are regularly inspected by state and federal regulatory authorities (including the FDA) to assure cGMP compliance.
Our facility is:
- Drug, food, and organic licensed
- cGMP compliant
- Prescription and OTC licensed
- FDA registered
- NSF certified
- Possesses a valid California Drug License
We take all of these licenses and certifications seriously because our products are relied on by millions of Americans. All of our products go through rigorous quality control processes to guarantee that they effective at providing treatment, and are safe for use by consumers.
Understanding Quality Control Compliance
With so many licenses and certifications, it can be difficult to understand what they all mean. Here are several of the licenses and certifications that we hold, and a brief explanation of their significance to you.
FDA Registered
PureTek Corporation is registered with the FDA, assuring compliance with strict governmental regulations applicable to all drug manufacturers, drug repackers, and re-labelers that conduct business within the United States.
cGMP Compliant
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
Prescription and OTC Licensed
Over-the-counter (OTC) license gives us permission to sell products directly to a consumer without a requirement for a prescription from a healthcare professional. On the other hand, a Prescription license allows a product to be sold only with a medical prescription.
NSF Certified
Our company complies with strict standards and procedures imposed by the National Sanitation Foundation. From extensive product testing and material analyses to unannounced plant inspections, every aspect of a product’s development is thoroughly evaluated before it can earn our certification. NSF certification is not a one-time event, but involves regular on-site inspections of manufacturing facilities and regular re-testing of products to ensure that they continue to meet the same high standards required to maintain certification over time.
Consistent Quality Starts with PureTek
Our family-owned business has been working in this industry for several decades. We understand how important regulatory compliance is to your company and especially to the consumer. We work hard to maintain the high standards that our facility is known for.
If your company is looking to research, develop, and manufacture personal care, supplement, or prescription & OTC drug products that meet your rigid standards, PureTek is the right fit for you. If you have questions, please contact PureTek today by calling (818) 837-5880. A member of our team would be more than happy to answer any questions that you may have.