PureTek Corp

Quality, Compliance & Regulatory

Quality, 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
  • A Verified Accredited Wholesale Distributor

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.

Quality, Compliance & Regulatory
PureTek Compliance and Quality

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.

Drug, Food, and Organic Licensed

Our facility is drug, food, and organic licensed, verifying that we have been inspected and audited by the appropriate government agencies to ensure compliance with all of these categories should your products require them.

PureTek holds a California Drug License, which allows us to manufacture prescription and OTC drugs within the state of California.

cGMP Compliant

PureTek’s facility complies with Current Good Manufacturing Practices (cGMP). The FDA’s cGMP qualification ensures proper design, monitoring, and control of manufacturing for processes and facilities. Pharmaceutical products have to be efficacious, and safe for use by consumers. cGMPs ensure that product batches are consistent and effective.

Prescription and OTC Licensed

Our facility is licensed to produce both prescription and OTC drugs. We manufacture a wide variety of Prescription and OTC drugs for companies and retailers looking to bolster their product lines.

Verified-Accredited Wholesale Distributor

PureTek holds a Verified-Accredited Wholesale Distributor license. This license guarantees that the wholesale portion of our business is in good standing, provides high-quality products that meet consumer standards, that all prescription drugs are documented and distributed legitimately, and is compliant with government regulations laid out by both the DEA and FDA. The VAWD certification requires a detailed inspection of all personnel, records, authentication and verification, handling of all returned, damaged, and outdated drugs, and policies and procedures.

NSF Certified

PureTek Corporation is NSF certified. NSF is an independent, voluntary, third-party quality assurance organization. We work directly with the NSF to ensure that all of our products meet their material analysis criteria, and that our plant meets their strict regulatory standards.

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.