Inspections, Compliance, Enforcement, and Criminal Investigations
Acacia Engineered Products LLC 20-Mar-08
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: (615) 366-7801
March 20, 2008
WARNING LETTER NO. 2008-NOL-09
Delivery Signature Requested
Mr. Eric J. Johnson, Owner
Acacia Engineered Products, LLC
1108 Harpeth Industrial Court
Franklin, Tennessee 37064
Dear Mr. Johnson:
On October 11 and 17, 2007, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, located at 1108 Harpeth Industrial Court, Franklin, Tennessee and determined your firm manufactures the IsoBalance. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 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.
Our inspection and a review of our records revealed the IsoBalance is adulterated under Section 501(f)(1)(B) of the Act [21 USC 351(f)(1)(B)], because you do not have an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act [21 USC 360e(a)], or an approved application for an investigational device exemption (IDE) under Section 520(g) of the Act [21 USC 360j(g)]. The device is also misbranded under Section 502(o) the Act [21 USC 352(o)], because you did not notify FDA of your intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act [21 USC 360(k)]. For a device PMA, the notification required by Section 510(k) of the Act [21 USC 360(k)], is deemed satisfied when a PMA is pending before the agency as required under Title 21, Code of Federal Regulations, Part 807.81(b) [21 CFR 807.81(b)]. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The IsoBalance also is misbranded under Section 502(o) of the Act [21 USC 352(o)], because the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510 of the Act [21 USC 360]. In addition, your device was not included in a list required by Section 510(j) of the Act [21 USC 360(j)].
This inspection also revealed your device is adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, its 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 21 CFR 820. Since your firm has failed to establish or implement the QS procedures required by Part 820, your device is in violation of these regulations.
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, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, PMA applications for Class III devices to which the QS 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 violations, from occurring again. 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.
This letter is not intended to be an all-inclusive list of the 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 Inspectional Observations, Form FDA 483, issued at the closeout 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 to bring your products into compliance.
Your response should be sent to Cynthia R. Gibson, Compliance Officer, U.S. Food and Drug Administration, at the above address. If you have any questions about the content of this letter, please contact Ms. Gibson at (251) 344-8208, extension 105.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483