Inspections, Compliance, Enforcement, and Criminal Investigations
Express Diagnostics International, Inc. 3/24/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
March 24, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 16
Paul K. Johnson
Chief Executive Officer
Express Diagnostics International, Inc.
1550 Industrial Drive
Blue Earth, Minnesota 56013
Dear Mr. Johnson:
During an inspection of your firm located in Blue Earth, Minnesota, on November 29, 2010, through January 20, 2011, investigators from the Food and Drug Administration (FDA) determined that your firm manufactures DrugCheck® drug of abuse tests. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 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 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 (CFR), Part 820. We received responses from you dated February 3, 15, and 25, 2011, concerning our investigators' observations noted on the Form FDA 483, List of Inspectional Observations (Form 483), that was issued to you. We address your responses below. Violations include, but are not limited to, the following:
1. Failure to establish adequate control over labeling activities as required by 21 CFR 820.120. Specifically, your standard operating procedure (SOP)MFG 37.04, Device Production, Inspection, and Testing, section 126.96.36.199, states that expiration dates are determined by (b)(4) in the device. The following lots contain (b)(4) that expire before the expiration date on the labeling of the finished product.
Lot No. Product Code Expiration Date (b)(4) Expiration Date 4-801 112210 70801-4 May 2012 December 2011 4A500 110310 65500-4A May 2012 March 2012 705 112210 30705 May 2012 August 2011 6A702 112910 60702-6A May 2012 March 2012 6A702 113010 60702-6A AUS May 2012 March 2012 A600 110310 60600-A May 2012 March 2012 205 110410 61205 May 2012 October 2011 4701 102910 70701-4 April 2012 December 2011 4801 102910 70801-4 April 2012 December 2011 6012 110310 31012-6 May 2012 August 2011 003 102510 31003 April 2012 March 2012
We reviewed your Form 483 responses concerning this violation and conclude that they are not adequate. It is unclear whether your firm determined if the expiration dating problem extends beyond the lots listed above. Furthermore, you have not completed correction or removal of all violative product that has been distributed.
2. Failure to establish adequate procedures for finished device acceptance, which is required by 21 CFR 820.80(d). Specifically, Device History Records
(DHRs) fail to demonstrate that products meet specifications, as noted below:
A. DHRs show that the following 12 lots of product containing buprenorphine (BUP) test strips were tested with (b)(4): 199110310 (2 lots), 043110110, 706102510, 727101910, 726111110, 207112910, 040120110, 717112910, 058112910, 670120110, and 6A930112910.
B. DHRs show that the following 13 lots of product containing alcohol test strips were tested with (b)(4) A901C 112910 (3 lots), A901C 112210, A901C 111610, A901C 120310, A901C 120210, A92S 100710, A015 110910, 6A930 111110, 6A-702-102610, 6A-702-102510, and 6A-930 102510.
We reviewed your Form 483 responses concerning this violation. You did not provide enough information to allow us to fully assess your corrections. You did not provide an updated DHR or a description of the required control materials and testing process. Furthermore, your correction of finished device acceptance violations for alcohol test strips is not expected to be completed until March 31, 2011.
Our inspection also revealed that your DrugCheck® drug of abuse tests are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 Reports of Corrections and Removals regulation. Your firm failed to submit a written report to FDA of a correction or removal of a device. The correction or removal was initiated to remedy a violation of the Act which might present a risk to health. A report is required by 21 CFR 806.10(a)(2). Specifically, by letter dated October 4, 2010, your firm notified customers that DrugCheck® Cup testing devices containing buprenorphine (BUP) and propoxyphene (PPX) did not have 510(k) clearance. To correct the problem, devices containing BUP and/or PPX strips were to be re-labeled as "forensic use only" or replaced with "dip devices." Your firm did not submit a written report to FDA of that correction or removal as required by 21 CFR 806.
Our inspection also reviewed the actions taken by your firm following Warning Letter MIN 09-12, dated March 12,2009, which cited your firm for failing to obtain marketing approval or clearance for your DrugCheck® devices. During the inspection, our investigators expressed serious concern regarding 510(k) coverage of your devices. Specifically, they questioned your firm's compliance with various agreements and procedures covering your relationship with (b)(4) supplies components (uncut sheets of testing strips) for the drug of abuse test devices manufactured by your firm. (b)(5)
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 Food and Drug Administration 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 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.
Your response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Mr. Philips at (612) 758-7133.
Finally, you should know that 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 close-out 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.
Gerald J. Berg