FDA Slams Firms with Second Warning Letters for Failing to Adequately Explain Corrective Actions

January 6, 2012

One warning letter is a bad thing. But two warning letters?

Most dietary supplement companies consider it a bad thing to get one warning letter following an FDA inspection. But two warning letters? Judging by second letters the agency sent two companies this past winter, it could very well happen-that is, if a company isn’t specific enough in demonstrating to FDA the first time around exactly how it plans to correct its errors.

FDA sent two warning letters in November, one to Golden Temple of Oregon LLC and another to Global Sweet Polyols Inc. Both letters cited the companies for various infringements, including cGMP violations the agency had noted during inspections. While acknowledging that each firm had followed up with FDA in response to the initial warning letter, to outline the corrective actions it planned to take, FDA said that the corrective actions were not described in adequate detail (and in some cases failed to include documentation proving instances in which the company claimed corrections had been made) to enable the agency to evaluate them. Thus, the agency sent second warning letters.

For instance, in the letter sent to Global Sweet Polyols, FDA wrote, “Your response further stated that you will discontinue all packaging and labeling operations. Your response does not, however, indicate, by date, when you will stop packaging and labeling dietary supplements. Your response also did not provide documentation of your plans to discontinue packaging and labeling operations.”

FDA also called the company out for not being specific enough when describing corrective actions related to establishing specifications for incoming product; for, when the company said it would instead turn packaging and labeling of its product over to a third party, not identifying who that third party would be; and for not being specific when describing how it would fix quality-control operations.

Also, when addressing written procedures for holding and distributing operations, FDA said that the company’s response with a “Product Receipt, Warehousing, and Distribution” written procedure failed to address the following conditions:

  • Holding the packaging and labels under appropriate conditions so that the packaging and labels are not adversely affected;

  • Holding the packaging and labels under conditions that do not lead to contamination or deterioration of packaging or labels;

  • Holding the reserve samples under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions;

  • Using the same container-closure system in which the packaged and labeled dietary supplement is distributed;

  • Retaining reserve samples for one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplement associated with the reserve sample.

To Golden Temple of Oregon, the agency said that in regards to written instructions in the firm’s Master Manufacturing Records, the company still needed to provide information on:

  • Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.

  • Procedures for sampling and a cross-reference to procedures for tests or examinations.

  • Corrective action plans for use when a specification is not met.

Regarding another area needing correction, FDA also told Golden Temple, “While your response outlined your plans to correct the violation, you did not provide any documentation to show that you have made the correction.”

On a side note, Global Sweet Polyols’ letter also cited the firm for having a canine in the plant that was neither a guide dog nor a guard dog-something cGMPs forbid (no animals or pests in the physical plant). FDA told the company that “our investigator observed you walking into the warehouse and packaging and labeling room with a dog in your arms. While 21 CFR 111.15(d)(1) allows guard or guide dogs in some areas of a physical plant if the presence of the dogs will not result in contamination of components, dietary supplements, or contact surfaces, you did not indicate that this dog was either a guard or guide dog.”

So, there’s that, too.

Nutritional Outlook thanks the American Herbal Products Association for the tip.