Steril Aire 7/2/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Avenue Silver Spring, MD 20993

 
July 2, 2010

WARNING LETTER

VIA UNITED PARCEL SERVICE

Dr. Robert Scheir
President and Chairman
Steril-Aire
2840 N. Lima Street
Burbank, California 91504

Dear Dr. Scheir:

The Food and Drug Administration (FDA) has learned that your firm is marketing the Steril-Zone Room Air Purifier with a UVC emitter in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Most recently on July 1, 2010, FDA's Center for Devices and Radiological Health (CDRH) viewed your company's website. The website makes numerous claims for the product, which is a device within the meaning of Section 201(h) of the Act.

Your web site contains statements that suggest that use of Steril-Zone Room Air Purifier with a UVC emitter in ventilation systems are effective against "mold, bacteria and viruses."
Statements include:

"Steril-Zone's germicidal UVC energy eliminates infectious organisms more successfully than air purifiers without UV lamps-even those with HEPA filters, which have only limited effectiveness against viruses, the tiniest of parasites. The compact but powerful unit also reduces or eliminates symptoms of allergies, asthma and other maladies triggered by biological contaminants and VOCs. It is ideal for apartments, condos and single family residences, offices, waiting rooms, schools, day care and senior facilities, and hotel rooms. Special features include:

1. A patented germicidal UVC Emitter effectively cleans the air of mold, bacteria and viruses."

The following claims also appear on the home page of your web site:

• "New UVC kit destroys microorganisms, including flu viruses, bacteria and mold."

• "Kills or, inactivates surface and airborne microorganisms that trigger allergy-asthma symptoms-including mold and mold spores, solvents and other VOCs."

• "Prevents the spread of infectious diseases caused by bacteria (including TB, Legionella, E. coli, and whooping cough) and viruses (including colds, flu, measles, German measles, chicken pox, small pox and SARS)"

These statements indicate that the Steril-Zone Room Air Purifier with UVC emitter is intended for use in the cure, mitigation, treatment or prevention of disease within the meaning of section 201(h) of the Act, 21 U.S.C. 321(h). As such the Steril-Zone Room Air Purifier with UVC emitter is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(t)(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).

The device is also misbranded under section 502(0) the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device 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(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.

You should take prompt action to correct the violations addressed in this letter. This is the second enforcement letter addressing the violative claims purported by your firm. The first Warning Letter was issued to you on April 2006 for your claims to mitigate the affects of SARS. Failure to promptly correct these current 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 such as the General Services Administration (GSA) are advised of the issuance of all Warning Letters about violative 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 violations, or similar violations, from occurring again. Include documentation of the corrective actions 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: George Kroehling, Acting Director, Division of Enforcement-A, Office of Compliance, Center for Devices and Radiological Health. If you have any questions about the content of this letter please contact: CAPT Ana Marie Balingit-Wines at 301-796~5497 or (Fax) 301-847-8137.

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 pertain only to the issues of pre-market clearance or approval of your devices and do not necessarily address other obligations you have under the Act. You should investigate and determine other possible violative claims, and take prompt actions to correct those violations in order to bring your products into compliance.

Sincerely yours,

/s/

Timothy Ultowski
Director,
Office of Compliance
Center for Devices and
Radiological Health

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Regancrest Holsteins, Inc.7/2/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Kansas City District Southwest Region 11630 West 80th Street Lenexa, Kansas 66214-3340 Telephone: (913) 752-2100

July 2, 2010

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
Ref: KAN 2010-05

Francis C. Regan, President
Regancrest Holsteins, Inc.
1095 Highway 9
Waukon, Iowa 52172-7744

Dear Mr. Regan:

On March 8 and 9, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1095 Highway 9, Waukon, Iowa. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

We found that you adulterated the new animal drugs DiMethox (Sulfadimethoxine 12.5% Solution Oral Form, ANADA 200-030), Agrimycin 100 (Oxytetracycline Hydrochloride Injection, ANADA 200-452), and TyloVed (Tylosin Phosphate 200 mg/mL Injection, NADA 138-955). Specifically, our investigation revealed that you did not use DiMethox, Agrimycin 100, and TyloVed as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. Title 21, Code of Federal Regulations (C.F.R.), 530.3(a) (21 C.F.R. 530.3(a)).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered sulfadimethoxine to a lactating dairy cow without following the route of administration and the conditions of use as stated in the approved labeling. Stilfafimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41 (a)(9). Our investigation also found that you administered oxytetracycline to a lactating dairy cow without following the conditions of use as stated in the approved labeling. Your extralabel use of oxytetracycline was not under the supervision of a license veterinarian, in violation of 21 C.F.R. 530.11 (a). Furthermore, our investigation found that you administered tylosin to a lactating dairy cow without following the route of administration as stated in the approved labeling. Your extralabel use of tylosin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the step you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has, been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Amy E. Devine, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 11630 West 80th Street, Lenexa, Kansas 66214-3340. If you have any questions about this letter, please contact Compliance Officer Amy E. Devine at 913-752-2719.

Sincerely,
/S/

John W. Thorsky
District Director
Kansas City District

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Haldiman, Keith And Patricia 6/30/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7133 FAX: (612) 334-4142

June 30, 2010
 

WARNING LETTER
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 10 - 17

 

Keith and Patricia Haldiman
N9035 Harvestore Road
Hilbert, Wisconsin 54129
 

Dear Mr. and Mrs. Haldiman:

On February 1 and March 11, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at N9035 Harvestore Road, Hilbert, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.
 

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)], a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act [21 U.S.C. § 360b). Further, under section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
 

Specifically,our investigation revealed that on or about June 22, 2009, you consigned (b)(4) to haul your dairy cow #(b)(4) identified with back tag #(b)(4), for slaughter as food. On or about June 22, 2009, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfamethazine at 37.280 parts per million (ppm) in liver tissue and 65.57 ppm in muscle tissue. The USDA/FSIS analysis also identified the presence of phenylbutazone in kidney tissue. The FDA has established a tolerance of 0.1 ppm for sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.670 [21 CFR 556.670]. However, this tolerance does not apply to sulfamethazine in lactating dairy cattle. There is no acceptable level of sulfamethazine residue in lactating dairy cattle. There is also no acceptable level of phenylbutazone residue in lactating dairy cattle. The presence of these drugs in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)].
 

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records that include the dosage amount, route of administration, and withholding period to ensure that treated cattle are not culled before labeled meat and milk withhold times are met. You also failed to maintain an inventory system for determining the quantities of drugs used to medicate your animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].
 

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute are in compliance with the law.
 

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
 

We are aware that your veterinarian, (b)(4) DVM, has discussed these matters with you. Specifically, he discussed the appropriate use of prescription medications and the use of medications that are prohibited for certain uses. We refer you to 21 CFR 530.41(a)(9) which prohibits the extralabel use of sulfonamide drugs (such as sulfamethazine) in lactating dairy cattle. Similarly, 21 CFR 530.41(a)(12) prohibits the extralabel use of phenylbutazone in female dairy cattle 20 months of age or older. (b)(4) also reviewed appropriate drug use record keeping and supplied you with appropriate forms.
 

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 

Your written response should be sent to Timothy G. Philips, Compliance Officer, U.S. Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.
 

Sincerely,
/S/

Howard E. Manresa
Acting Director
Minneapolis District

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Closed Out Letter

• Haldiman, Keith And Patricia - Closed Out Letter 11/15/10

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