Regulatory Focus™ > News Articles > Trust but Verify: Supplement Manufacturer's Reliance on Trust not Sufficient to Meet CGMPs, Says FDA

Trust but Verify: Supplement Manufacturer's Reliance on Trust not Sufficient to Meet CGMPs, Says FDA

Posted 11 September 2013 | By Alexander Gaffney, RAC

Trust is the foundation of many good relationships, but as a new Warning Letter to a dietary supplement manufacturer illustrates, it's not the foundation of a good manufacturing practices (GMP) system.

The 15 April 2013 letter to Irenda Corporation of Los Angeles, CA, references a September 2012 inspection during which FDA inspectors reportedly found "significant violations" of current GMP regulations for dietary supplements under 21 CFR 111. The reported violations were enough for FDA to conclude that the company's products were adulterated under the Federal Food, Drug and Cosmetic Act (FD&C Act).

The first alleged violation noted in the letter may be the most damning: Irenda had no idea whether the raw ingredients sold to it by an outside provider were of proper quality, potency or purity.

"At the time of inspection, you stated that because of the 'trust' between you and your customers, you had not tested the ingredients used in the manufacturing of your dietary supplements to verify their identity prior to use."

FDA noted dryly that, trust be damned, the company still wasn't exempt from the requirements of 21 CFR 111.75(a).

Those deficiencies snowballed into other related ones as well, FDA explained. For example, FDA said the company failed to confirm the identity of other, non-active ingredients in the products-a violation under 21 CFR 111.70(b). Ordinarily, a certificate of analysis (COA) is required to be obtained from a supplier to confirm their testing. Irenda failed to validate the reliability of the suppliers' COA for lots of glycerin, potassium hydroxide and citric acid.

Irenda also failed to verify the identity of finished batches of its product, resulting in potentially suspect products being distributed to customers.

FDA's implicit advice for Irenda is quite similar to the cold war proverb: Trust, but verify.

Of course trust is only part of the equation. FDA's Warning Letter goes on to note that it found the company using "tape and newspaper" to stifle pipe leaks, long grass next to the facility that could invite in mice or insects, its water supply room containing "standing water from the adjacent sewage drain," and abandoned equipment housed outside the facility (which, like the grass, could invite pests).


Warning Letter to Irenda


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