Mr. Brad Mason, President
Blackstone Medical, Inc.
1211 Hamburg Turnpike, Suite 300
Wayne, NJ 07470
CMS # 41958
Dear Mr. Mason:
During an inspection of your firm, located in Springfield, MA, on September 16 through October 7, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ICON™ Modular Spinal Fixation System (ICON™ System). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received your responses dated October 31, 2008 and January 31, 2009 concerning our investigator’s observations noted on FDA Form 483, List of Inspectional Observations that was issued to you. We address these responses below, in relation to each of the noted violations.
These violations include, but are not limited to, the following:
1) Failure to adequately establish and maintain a risk analysis of the device as part of your design validation, as required by 21 CFR 820.30(g). In October 2007, after design changes to the ICON™ System were made and as a part of your design validation for that change, your firm failed to adhere to your own risk management procedures.
2) Failure to adequately establish and maintain Corrective and Preventive Action (CAPA) procedures to include requirements for investigating the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2).
3) Failure to adequately establish and maintain corrective and preventive action procedures that address verification or validation of the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device prior to implementation, as required by 21 CFR 820.100(a)(4). For example, your firm verified the effectiveness of CAPA 006-002 by calculating the rate of complaints after implementation of design changes. However, your firm’s CAPA SOP does not address appropriate statistical methods to be used to verify or validate actions as effective or justification of the statistical methods used.