Inspections, Compliance, Enforcement, and Criminal Investigations
Facet Technologies, LLC 5/19/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Atlanta District Office
May 19, 2011
Kevin Seifert, CEO
Facet Technologies, LLC
112 Town Park Drive
Kennesaw, GA 30144
Dear Mr. Seifert:
During an inspection of your firm conducted at 101 Liberty Industrial Parkway in McDonough, GA on March 9–30, 2011, an investigator from the U.S. Food and Drug Administration (FDA) determined that your firm packages and assembles blood lancets and lancing devices used for blood glucose monitoring. These products are devices within the meaning of Section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 321(h)] in that 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 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) regulations found at Title 21 of the Code of Federal Regulations (CFR) Part 820 (CFR Part 820).
A form FDA 483, Inspectional Observations, was issued at the close of the inspection. Your firm’s management informed our investigator that a written response to the FDA 483 would be forwarded to this office. Your firm’s management was advised by our investigator that the response must be submitted within 15 business days from the inspection closeout on March 30, 2011. We acknowledge receipt of your FDA 483 response letter, dated May 6, 2011. Be advised that your FDA 483 response will be evaluated in conjunction with any further written materials provided in response to this warning letter. The violations documented on the FDA 483 issued include, but are not limited to, the following:
1. Where the results of a process cannot be fully verified by subsequent inspection and test, your firm failed to validate a process with a high degree of assurance and with approval according to established procedures, as required by CFR Part 820.75(a). Your firm’s mold validation and housing press validation for the OneTouch Delica Lancing Device/Aurora had process capability (Cpk) out-of-specifications that were not investigated or evaluated. Examples of this deficiency as documented by our investigator include, but are not limited to, the following observations. Device components, such as the bottom housing, top housing, and depth dial, had Cpk values that were out-of-specification during Operational Qualification (OQ) and were not evaluated according to protocol prior to proceeding to Process Qualification (PQ). Also, your firm’s current Mold Qualification protocol, MQ 09 – MCD – 037, has not been updated to correspond with critical-to-quality dimension acceptance criteria changes. Additionally, your firm did not have evidence of deviations where front and back height process capabilities of (b)(4) were not realized during validation of the (b)(4) Model (b)(4) for Project Aurora Assembly 0600020 for lines (b)(4)
2. Failure to maintain adequate control of nonconforming product in that an evaluation of the nonconformance, including a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance, was not performed as required by CFR Part 820.90(a). For example, Nonconforming Reports N10-0408, N10-0383, and N10-0384 document OneTouch Delica Lancing Device lots R182007 and R176014 exhibited drop test functional test failures, uneven seam failures, and back height out-of-specifications. However, the lots were released “accept as is” without evidence of investigation of the issues or rationale for releasing the non-conforming products.
3. Failure to conduct a risk analysis when appropriate as required by CFR Part 820.30(g). For example, a risk analysis was not performed when design changes were made to the button trigger, enclosure top device, and the base mechanical device of the Alpine Lancing System to prevent reoccurrence of device jams.
4. Failure to adequately document corrective and preventive action activities and/or results as required by CFR Part 820.100(b). For example, six of seven corrective actions reviewed remained open beyond the 90-day limit or were closed beyond the 90-day limit set forth in your Corrective and Preventive Action Procedure, QAP-017, Rev. Q date 10/4/2010, without documented rationale and/or approval of an extension.
You should take prompt action to correct the violations addressed in this letter and noted on the FDA 483 issued at the closeout of the inspection. 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, and/or civil money penalties. Also, federal agencies are advised of the issuance of all warning letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the quality system regulation deviations are reasonably related, 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.
Please notify this office in writing within fifteen (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 ones, from occurring again. Include documentation of corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
This letter is not intended to be an all-inclusive list of the violations at your firm. 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 form FDA 483, Inspectional Observations, 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.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer; 60 – 8th Street NE; Atlanta, GA 30309. If you have any questions, please contact Mrs. Morton at 404-253-1285.
John R. Gridley
Atlanta District Office