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U.S. Department of Health and Human Services

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Enforcement Actions

Folsum Metal Products, Inc. dba FRONTIER DEVICES 8/27/09

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802

 

August 27, 2009

 

WARNING LETTER NO. 2009·NOL-18

 

VIA FEDERAL EXPRESS
Delivery Signature Requested

 

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.

4. Failure to document disposition of nonconforming product. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use, as required by 21 CFR 820.90(b)(l). [Reference: FDA 483, Item 6] For example, of the (b)(4) distraction drivers (Lot J03401) manufactured at your firm during March 26-29, 2008, at least (b)(4) rivers were documented as having nonconforming specifications. You told our investigator the lot of drivers were prototypes and were released for distribution. Your firm did not maintain documentation of the review, disposition, or justification for use of the nonconforming drivers.

Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.

5. Failure to validate processes where the results of a process cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). [Reference: FDA 483,Item 8] For example, your firm has not approved according to established procedures, or validated with a high degree of assurance, the following processes: cleaning, passivation, laser etching, and grinding processes used to manufacture distraction pins, distraction pin drivers, and K-wires. Specifically, your firm failed to establish validation methods and conduct validation studies to ensure the predetermined specifications of these devices are consistently being met after undergoing the above-mentioned processes.

We reviewed your response and concluded it is inadequate because you have not included established procedures for, or provided information of validation of, the above-mentioned processes.

6. Failure to establish and maintain procedures to ensure all purchased product and services conform to specified requirements, as required by 21 CFR 820.50. [Reference: FDA 483, Item 10] For example, you failed to evaluate your suppliers on a semi-annual basis, as required by your purchasing control quality system procedure.

Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.

7. Failure to maintain, in your complaint files, records of investigations made under 21 CFR 820.198, which shall include any device identification(s) and control number(s), as required by 21 CFR 820.l98(e)(3). [Reference: FDA 483, Item 11] For example, the records of the investigations of the following complaints lacked device identification(s) and control numbers(s):

a. Complaint No. 164080702, dated July 3, 2008, involving a Distraction Pin Driver;

b. Complaint No. 164080703, dated July 23, 2008, involving a Distraction Pin;

c. Complaint No. 16407008, dated September 4, 2007, involving a Coping Fixation Screw; and,

d. Complaint No. 16408009, dated June 21, 2008, involving a (b)(4)

Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.

Our inspection revealed your (b)(4) dental implants are misbranded under Section 502(t)(2) of the Act [21 USC 352(t)(2)], as your firm failed or refused to furnish material or information with respect to the devices as required by Section 519 of the Act [21 USC 360i] and 21 CFR 803- MDR regulation. Significant deviations documented on the FDA 483 include, but are not limited to, the following:

1. Failure to submit an MDR to FDA within 30 calendar days after the day you receive, or otherwise become aware of, information reasonably suggesting a device you market may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
[Reference: 483, Item 1] For example:

a. Complaint 16406007, dated October 31, 2006, involving (b)(4) implant, documents an instance of failure to osseointegrate where a patient experienced granulation of tissue and infection resulting in revulsion and removal of the implanted device; and,

b. Complaint 16405001, dated February 3, 2005, involving a (b)(4) implant, documents an instance where a patient experienced bone loss and implant breakage.

These complaints represent MDR reportable events as failure to osseointegrate may have caused or contributed to a serious injury, i.e., bone loss and infection resulting in revulsion of the implant and requiring removal of the implanted device. These complaints were previously cited as Observation 1 on the FDA 483 issued to your firm on February 7,2007. FDA received MDRs for these two complaints in 2009.

Your response to this observation included copies of the MDR reports for the above complaints. Note your response is inadequate as your submission is beyond the 30-day timeframe noted above. For future MDRs, you must use the current FDA MEDWATCH Form 3500A, as required by 21 CFR 803.11, or an electronic equivalent as approved by 21 CFR 803.14. To obtain this form refer to 21 CFR 803.11. Additionally, all written MDRs must be submitted to the address listed in 21 CFR 803.12.

2. Failure to submit an MDR to FDA within 30 calendar days after the day you receive, or otherwise become aware of, information reasonably suggesting a device you market has malfunctioned; and, this device, or a similar device you market, would be likely to cause, or contribute to, a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).

For example, Complaint 16408009, dated June 19, 2008, involves a (b)(4) implanted denture where the snap caps became worn and lost retention after 4 weeks, which required explantation and replacement. Worn snap caps are considered a reportable malfunction because, if the malfunction were to recur, it would likely cause or contribute to a serious injury, i,e., explantation and removal of gum tissue and bone. Though not documented on the FDA 483, this complaint represents an MDR reportable event. To date, FDA has not received an MDR for this complaint.

3. Failure to conduct an investigation of each event and evaluate the cause of the event, as required by 21 CFR 803.50(b)(3). For example,

a. Complaint 16406007, dated October 31, 2006, involving a (b)(4) implant, does not document any investigation evaluating the cause of the adverse event; and,

b. Complaint 16405001, dated February 3, 2005, involving a (b)(4) implant, does not document any investigation to determine patient status, whether the device design could have led to the bone loss, or results of the examination of the implant to evaluate the cause of the event.

Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a-future inspection.

Though not documented on the FDA 483, the following deficiencies were noted:

• Failure to maintain a record of an investigation per 21 CFR 820.198. The record of the investigation shall include the name, address, and phone number of the complainant, as required by 21 CFR 820.198(e)(4). For example, the record for Complaint 1640500] did not include information on the name, address, or phone number of the complainant. This information was included in the Medical Device Report 6307795730-2006-1001.

Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.

• Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA per 21 CFR 803, Medical Device Reporting (MDR), as required by 21 CFR 820, 198(a)(3). For example, your firm's complaint file procedure, Quality System Requirement 820.198 Complaint File, collected during our inspection, does not establish the requirement to review all complaints to determine whether the complaint represents an event which is required to be reported to FDA as an MDR per 21 CFR 803.

We reviewed your response, which includes a MDR procedure, QSP 199, and concluded it is inadequate as it does not include a review process or procedure for determining when an event meets the criteria for reporting.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, or civil money penalties. Federal agencies are advised of the issuance of all warning letters regarding devices so they may take this information into account when considering the award of contracts. Additionally, premarket applications for Class III devices will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Your firm's procedure QSP 199 contains an Annual Certification requirement. The Safe Medical Devices Act of 1990 (Pub. L. No.1 01-629) required each manufacturer, per Section 519(d) of the Act [21 USC 360i(d)], to submit to FDA annually a statement that either the manufacturer did file a certain number of reports under Section 519(a) of the Act [21 USC 360i(a)] or the manufacturer did not file any report under Section 519(a) of the Act. However, Section 213(a)(2) of the FDA Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) repealed Section 519(d) of the Act. Therefore, please update your firm's QSP 199 to delete the annual certification requirement repealed by FDAMA in 1997.

Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Rebecca A. Asente, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact: Ms. Asente at (504) 219-8818, extension 104.

This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483, issued at the conclusion of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely,

/s/

H. Tyle Thornburg
District Director
New Orleans District Office

Enclosure: Form FDA 483, dated February 23,2009