Regulatory Focus™ > News Articles > Paintbrush, Cardboard and Black Residue Earn Supplement CMO a Warning Letter

Paintbrush, Cardboard and Black Residue Earn Supplement CMO a Warning Letter

Posted 24 October 2013 | By Alexander Gaffney, RAC

One week after logging a record low for posted Warning Letters-that is, zero posted-the US Food and Drug Administration (FDA) is back in action, logging a normal, if slightly higher, number of letters. And at least one of those letters shows rampant and disturbing violations at a dietary supplement manufacturer's facility.

The letter to New Jersey-based DNE Nutraceuticals, a self-described contract manufacturer, references a lengthy inspection conducted by FDA between 19 February and 11 March 2013 at the company's Farmingdale, NJ facility.

Like many facility-based inspections, the bulk of FDA's observations pertain to current good manufacturing practices (CGMP), which are regulated under 21 CFR 111 for dietary supplements and are conceptually similar to those maintained for pharmaceutical products.

However, FDA inspectors found "significant" CGMP violations at the facility, resulting in a lengthy Warning Letter to DNE Nutraceuticals.

In its 2 August 2013 letter to DNE, FDA chides the company for a long list of alleged violations, among them:

  • failing to ensure manufacturing specifications for identity, strength, purity or composition were being met, either during or after the manufacturing process
  • failing to test component ingredients prior to their use in the manufacturing process, as required per 21 CFR 111.75(a)(1)(i)
  • failing to prepare or follow written master manufacturing records as required under 21 CFR 111.205 and .210 in a litany of noted examples
  • The "Supplement Facts" label used for two products failed to contain information in the required format or with the required information.

Other alleged violations were described in more colorful detail. For instance, FDA wrote that its investigators discovered in-process materials being stored "outside designated areas, such as in hallways" without proper or consistent labeling.

In another series of examples, FDA said the physical conditions of the facility were not up to standards. Investigators observed an "accumulation of black residue" on an important piece of equipment, buckets being used to transport ingredients being re-used without first being sanitized, improperly cleaned manufacturing equipment, a hopper lid that had been replaced by a "piece of cardboard," and a "frayed and stained medium sized wooden paintbrush" being used to cram ingredients into a machine.

Still other examples cited in the letter included the use of unsanitary gloves by production workers, insufficiently trained quality control personnel, a "white powder" covering much of the facility, and the use of poorly designed equipment that raised the chance of contamination.

While DNE had responded to an earlier letter issued by FDA-most likely a Form 483-the agency summarily rejected many of the company's responses as being inadequate and lacking sufficient detail to assuage the agency's concerns.

Warning Letter to DNE Nutraceuticals

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