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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Micro Distributing II, Ltd. 8/26/11

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

August 26, 2011

Ref: 2011-DAL-WL-18

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Roy G. Whiteside, Jr.
Chief Executive Officer
Micro Distributing II, Ltd.
620 Kennedy Court
Belton, TX 76513

Dear Mr. Whiteside:

The Food and Drug Administration (FDA) conducted an inspection of your firm located in Irving, TX, on July 13 through 16, 2010, and has reviewed your firm's website at http://www.micro-distributing.com, most recently on August 12, 2011. We determined that your firm markets and distributes in-vitro diagnostic (IVD) rapid screening tests for drugs of abuse. 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.

Your STATDIP® (Urine Dip Card Devices), STATCASSETIE® (Urine Cassette Devices), STATCUP® and STATCUPII® (Urine Test Cup Devices), and STATSWAB® (Oral Fluid Test Devices) are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 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 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. § 807.81(a).

As of August 24, 2011, we have not received your firm's response to the inspectional observation noted on the Form FDA 483 (lnspectional Observations) that was issued to you.

Our inspection documented that all of your private label brands are manufactured by (b)(4) and are (b)(4) through (b)(4). A review of our records indicates that we cleared two 510(k) premarket notifications submitted by (b)(4) for the (b)(4) for testing of urine for amphetamine, methamphetamine, opiates, cocaine, cannabinoids, and phencyclidine, and (b)(4) for testing of urine for nortriptyline, secobarbital, mdma, oxazepam, oxycodone, and methadone. These two cleared 510(k)s cover cleared uses for your urine tests (STATCUP, STATCUPII, STATDIP, and STATCASSETTE), but there is no clearance or approval for your saliva test (STATSWAB).

A review of your firm's website and online product catalog reveal that you are promoting your urine tests for new indications not covered by the cleared 510(k)s. For example, you promote these tests for (1) testing propoxyphene (PPX) and buprenorphine (BUP) in the urine of the donor, (2) detecting the presence of adulterants (for example by measuring pH [PH], Oxidants [OX], and Specific Gravity [SG]) in urine, (3) measuring urine temperature at the time of the test, and (4) testing up to 15 drugs in one urine test. For example:

"STATCUP **** CALL FOR A FREE SAMPLE!"
"TEST FEATURES"

• "Temperature Strip"
• "Test Up to 15 Drugs (see below)"
• "Available with Built-in Adulterants"

"STATCASSETTE ****CALL FOR A FREE SAMPLE!"
"TEST FEATURES"

• "Test Up to 15 Drugs (see below)"
• "Available with Built-in Specimen Validity Test!"

"STATDIP ****CALL FOR A FREE SAMPLEI"
"TEST FEATURES"

• "Available with Built-in Adulterants"
• "Test up to 15 drugs (see below)"

"Drugs of Abuse:"
"Marijuana"
"Cocaine"
"Opiates"
"Methamphetamine"
"Amphetamine"
"Phencyclidine"
"Benzodiazepines"
"Barbiturates"
"Methadone"
"Ecstasy"
"Tricyclic Antidepressants"
"Oxycodone"
"Propoxyphene*"
"Buprenorphine*"
"6-Mono Acetylmorphine*"

"*For Forensic Use Only"

"Adulterants:"
"pH (acidic additives)"
"Specific Gravity (sample dilution)"
"Oxidants (bleach/oxidizing agents)"

"STATSWAB **** CALL FOR A FREE SAMPLE!"
"TEST FEATURES"

• "Fully Integrated"
• "Simple Mouth Swab"
• "No Steps to Activate"
• "Observable"
• "No Restroom Needed"
• "Test up to 11 Drugs"
• "Fast"
• "Accurate"
• "Affordable"
• "Transport Sample to Lab"

"TEST AVAILABLE"
"Drugs of Abuse:"

"Marijuana"
"Cocaine"
"Opiates"
"Phencyclidine"
"Methamphetamine"
"Amphetamine"
"Benzodiazepines"
"Oxycodone"
"Barbiturates"
"Methadone"
"Buprenorphine"

"STATSWAB®"
"The STATSWAB® is a NEW and INNOVATIVE, fully integrated oral fluid drug screen device. The STATSWAB® is the simplest and fastest oral fluid drug screen on the market. Simply swab the mouth and screw the cap on. It's that easy! See back for details." "Forensic Use Only."

In addition, the product catalog posted at your firm's website at http://www.microdistributing.com/stat_swab.cfm lists the following:

STATDIP® (Urine Dip Card Devices)
DBU-114 BUP 10 -  buprenorphine
DPP-114 PPX 300-  propoxyphene
SDP-354-A           5-drug panel plus test for adulterants SG/PH/OX
SDP-51 04-A        10-drug panel including PPX plus test for adulterants SG/PH/OX
SDP-1114            11-drug panel including PPX
SDP-1124            12-drug panel including PPX

STATCASSETTE® (Urine Cassette Devices)
BUP-102 BUP 10 -  buprenorphine
DPP-102 PPX 300 - propoxyphene

STATCUP® (Urine Test Cup Devices)
SCP-1247-A    4-drug panel plus test for adulterants SG/PH/OX
SCP-3257-A    5-drug panel plus test for adulterants SG/PH/OX
SCP-1257-A    5-drug panel plus test for adulterants SG/PH/OX
SCP-6157-A    5-drug panel plus test for adulterants SG/PH/OX
SCP-2167-A    6-drug panel plus test for adulterants SG/PH/OX
SCP-4167-A    6-drug panel plus test for adulterants SG/PH/OX
SCP-5167-A    6-drug panel plus test for adulterants SG/PH/OX
SCP-2177-A    7-drug panel plus test for adulterants SG/PH/OX
SCP-3387-A    8-drug panel plus test for PPX and adulterants SG/PH/OX
SCP-1287-A    8-drug panel plus test for adulterants SG/PH/OX
SCP-2187-A    8-drug panel plus test for adulterants SG/PH/OX
SCP-1297-A    9-drug panel plus test for adulterants SG/PH/OX
SCP-21107-A  10-drug panel plus test for adulterants SG/PH/OX
SCP-31107     10-drug panel including PPX
SCP-31107-A  10-drug panel including test for PPX and adulterants SG/PH/OX

STATCUPII® (Urine Test Cup Devices)
SCPII-2167-A         6-drug panel plus for adulterants SG/PH/OX
SCPII-41107-A       10-drug panel plus for adulterants SG/PH/OX

STATSWAB® (Oral Fluid Test Devices)
SSB-148, SSB-158, SSB-168, SSB-268, SSB-368, SSB-188, SSB-1108

Because these represent major changes in the intended use of the screening tests, your firm is required to submit a new 510(k) for these devices. See 21 CFR 807.81 (a)(3)(ii).

We note that your saliva screening test and some of the unapproved uses of your urine screening tests are labeled "For Forensic Use Only." However, our inspection documented that your firm has not restricted sales to law enforcement customers, and that a significant quantity of your sales for these tests are to employment staffing agencies, health clinics, home healthcare agencies, and other entities that are not involved in law enforcement. Thus, these tests are not intended only for forensic use, are not properly labeled as such, and require 510(k) clearance prior to marketing.

You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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.

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 violation(s), or similar violation(s), 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 Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the lnspectional Observations, Form FDA 483 (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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.

Sincerely,

/s/

Reynold R. Rodriguez Jr.
Dallas District Director