Records, Specs Dominate Oza GMP Warning

WASHINGTONAn FDA good manufacturing practice (GMP) inspection of Oza Compound Products has revealed significant violations that cause the company's products to be considered adulteration under the regulation. Similar to common violations by other inspected dietary supplement facilities, Oza management was alerted to its failure to set several important manufacturing specification, including identity and purity, in addition to several batch and master manufacturing record (MMR) deficiencies and labeling problems.

FDA inspectors  noted Oza failed to set specifications for identity, purity, strength and composition for each component used in the manufacturing of its Oza Compound dietary supplement product. Such specifications were also not established for the finished product. The agency reminded the company establishing the required specifications will not be enough, but the company must also ensure the specs are met. Oza responded to FDA's 483 notification of these violations, but the agency said the company did not specify specific corrective action(s) taken to solve these problems.

Among the  numerous batch and MMR records failures, Oza was notified for missing required information on identity of equipment and processing lines used to produce the batches; detailed maintenance and cleaning records; actual operation monitoring results; batch and cross-reference testing results; and sign-off by personnel overseeing various control points in the MMR. Detailed specifications on corrective actions for material that fails to meet spec were also missing.

The labeling violations reported by inspectors include promoting products for conditions that cause them to be considered drugs. These therapeutic claims include cancer, cholesterol, cold and flu, and immune system claims. FDA noted the products are no generally recognized as safe (GRAS) for the conditions claimed and are, therefore, new unapproved drugs. AN even more glaring labeling issue was Oza's failure to identify the products on the labels as dietary supplements, making them misbranded. Certain Oza product labels also failed to declare ingredients in the Supplement Facts Panel that are implied elsewhere on the label, inappropriately lists ingredients in the Supplement Facts Panel that do not belong there, and list incorrect daily values for several ingredients.

INSIDER's Take:

The specification and records failures listed in the 483 report and this warning letter are indicative of companies that failed to properly prepare for the implementation of the supplement GMPs. These are correctable violations, but continued failure to properly address these violations will only bring increased enforcement and bad press.

The labeling violations may not be sinister, but they reflect an ignorance or carelessness on the part of the company's operations and management. In fact, FDA noted several listed ingredients did not use the proper nomenclature for those ingredients and were listed in the wrong order. This seems to indicate a lack of knowledge of proper labeling, something education could solvethere are plenty of industry resources for this type of issue. Again, these violations can be corrected; perhaps the oversight and assistance of a expert consultant in this area would be helpful to Oza, which has a range of violations to address with FDA.

Full text of the Oza Compound warning letter can be found at FDA Online .