Aubrey Clint Folsom, Jr.
President, CEO, and Owner
Folsom Metal Products, Inc.
DBA Frontier Devices, Inc.
153-A Cahaba Valley Parkway
Pelham, Alabama 35214
Dear Mr. Folsom:
During an inspection of your firm, located at 153-A Cahaba Valley Parkway, Pelham, Alabama, on February 3-6,9-10,12, and 23,2009, an investigator from the U. S. Food and Drug Administration (FDA) determined your firm is a manufacturer of (b)(4) dental implants and orthopedic surgical instruments for the spine. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 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 are intended to affect the structure or function of the body.
This inspection revealed your orthopedic surgical instruments for the spine are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)] as the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). We received responses from Mr. Don Petersen, Ph. D., Director of Quality Assurance and Regulatory Affairs, dated March 25, 2009 and May 21,2009, concerning our investigator’s observations noted on the FORM FDA 483, List of Inspectional Observations, (FDA 483) issued to you. The responses are addressed below in relation to each violation. The violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). [Reference: FDA 483, Item 2] For example, you failed to establish procedures for the following requirements:
a. Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
b. Investigating the cause of nonconformities relating to product, processes, and the quality system;
c. Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
d. Verifying or validating the CAPA to ensure such action is effective and does not adversely affect the finished device; and,
e. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.
Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.
2. Failure to document all required CAPA activities and results, as required by 21 CFR 820.100(b). [Reference: FDA 483, Item 2] For example, in response to complaints 164080702 and 164080703 (dated July 3,2008, and July 23,2008, respectively) involving three distraction pin drivers and a distraction pin, your firm performed failure investigations and took corrective action involving changes in product design or production processes. However, your firm failed to document these CAPA activities and results.
Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.
3. Failure to maintain device master records (DMRs) for your Model Number 1 K-wire and Model Number 2 K-wire, as required by 21 CFR 820.181. [Reference: FDA 483, Item 5] For example, your firm has not included, or referenced the location of, the following required
information for the K-wires you manufacture:
a. Device specifications;
b. Production process specifications;
c. Quality assurance procedures and specifications;
d. Packaging and labeling specifications; and,
e. Maintenance and servicing procedures and methods.
We reviewed your response and concluded it is inadequate because you have not included, or referenced the location of, the missing information.
