Is X12 Co., LTD. Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

During an inspection of your firm located in Sofia, Bulgaria on September 5, 2016, through September 7, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile reflective marker spheres. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

4.    Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(e). For example:

ii.  Whether the device was being used for treatment or diagnosis.

Potential Health Risks

3.    Failure to establish and maintain procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). For example:

iii.  The relationship if any, of the device to the reported incident or adverse event.

b.  CAPA activities are inadequate in that they do not include investigation details and verification and/or validation activities to ensure that such actions are effective and do not adversely affect the finished device.

Regulatory Context

This inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21 , Code of Federal Regulations (CFR), Part 820.

We received responses from you, dated September 21, 2016, and October 23, 2016, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1.    Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30. For example, the following deficiencies were observed during a review of the design activities for the sterile reflective marker spheres: