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Audits, Quality Up for Contract Manufacturers

contract manufacturing

An increasing number of dietary supplement distributors and marketers are auditing the facilities of their contract manufacturers. The audits reflect the industry's growing awareness that FDA is holding accountable all businesses in the distribution chain for compliance with current good manufacturing practices (cGMPs).

In letters to distributors and marketers, FDA has underscored that outsourcing manufacturing does not relieve a company from complying with cGMPs. Agency officials maintain these businesses are ultimately responsible for ensuring all phases of production meet the regulations and that the products are not adulterated.

Compliance is crucial given that a company can be held liable under the Federal, Food, Drug and Cosmetic Act for introducing adulterated food in interstate commerce.

Marketers must produce documentation to establish they are meeting cGMP responsibilities. FDA has been auditing many dietary supplement firms that outsource their manufacturing, compelling marketers to review batch records, certificates of analysis, raw material specs and other documents of their contract manufacturers.

Some contract manufacturers acknowledge that testing for ingredients remains one of the most challenging areas of their businesses. Warning letters from FDA indicate some contract manufacturers are struggling to meet the testing requirements. Still, others contend they are exceeding the testing requirements specified in the cGMPs, helping to them distinguish themselves in a market that still faces significant non-compliance.

  • An increasing number of dietary supplement distributors and marketers are auditing the facilities of their contract manufacturers.
  • In letters to distributors and marketers, FDA has underscored that outsourcing manufacturing does not relieve a company from complying with cGMPs.
  • Some contract manufacturers acknowledge that testing for ingredients remains one of the most challenging areas of their businesses.

For more insight, read the full Report "Contract Manufacturing Reporting More Consumer Audits, Quality Agreements."

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