AA Dairy 30-Mar-05

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District 158-15 Liberty Avenue Jamaica, NY 11433

 

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

March 30, 2005

File No: NYK 2005-08

Aaron L. Aman, Partner
AA Dairy
56 Footes Crossing Rd.
Candor, NY 13743-1426

Dear Mr. Aman:

On December 8 and 15, 2004, U.S. Food and Drug Administration investigators conducted an inspection at your farm located in Candor, New York. This inspection confirmed that you offered three animals for sale for food that were adulterated within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4)of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U .S.C. Sections 342(a)(2)(C)(ii) and 342(a)(4)]. The inspection also revealed that you caused medicated feeds to be adulterated within the meaning of Section 501(a)(6 of the Act) [21 U.S.C. Section 351(a)(6)J.

On or about October 18, 2004, you offered for sale a calf identified with sale tag [redacted] slaughter as human food. The calf was sold to and slaughtered at [redacted] USDA analysis of tissue samples collected from that animal identifed the presence of 4.69 ppm neomycin in kidney tissue.

On or about March 29, 2004, you offered for sale a calf identified with backtag [redacted] for slaughter as human food. The calf was sold to and slaughtered at [redacted] USDA analysis of tissue samples collected from that animal identified the presence of 5.05, ppm neomycin in kidney tissue.

On or about March 29, 2004, you offered for sale a calf identified with backtag [redacted] for slaughter as human food. The calf was sold to and slaughtered at [redacted] USDA analysis of tissue samples collected from that animal identified the presence of 2.13 ppm neomycin in kidney tissue.

There is no established tolerance for neomycin in calves (Title 21 Code of Federal Regulations,Section 556.430). The presence of this drug at the level reported in these animals causes the food to be adulterated.

Our investigation also found that you hold animals on your farm under conditions that are so inadequate that diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records for bull calves fed medicated milk replacer, lack a system for assuring that the milk replacer is used in a manner not contrary to label instructions, and lack a system for assuring the medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous drug residues from edible tissues. Foods from animals held under such conditions are adulterated under Section 402(a)(4) of the Act [21 U.S.C. Section 342(a)(4)].

You adulterated the medicated feed [redacted] Calf Milk Replacer, which contains neomycin, when you used it in calves to be processed for veal contrary to the warning on the label. Since the Act does not permit the extralabel use of medicated feeds, your actions cause the medicated feed to be unsafe to use under Section 512(a) of the Act [21 U.S.C. 360b(a)] and adulterated within the meaning of Section 501(a)(6) of the Act [21 U.S.C. Section 351(a)(6)].

You should not consider this an all-inclusive list of violations existing at your facility. As a producer of animals offered for use as food, you are responsible for assuring your overall operation and the foods you distribute are in compliance with the law.

You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to achieve prompt corrective action may result in regulatory action without further notice, such as seizure and/or injunction.

It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Federal Food, Drug, and Cosmetic Act. The fact that you caused the adulteration of an animal that was sold and offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act. Likewise, the fact that you caused the adulteration of a medicated feed that had been sold in interstate commerce is sufficient to hold you responsible for a violation of the Act.

Please notify this office in writing, within 15 working days, of the steps you have taken to bring your firm into compliance with the law. Your response should include each step you have taken or will take to prevent the recurrence of similar violations. If corrective action cannot be completed within 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 response should be directed to Richard T. Trainor, Compliance Officer, at the following address: FDA, 300 Hamilton Ave., White Plains, New York 10601.

Sincerly,

/S/

Jerome G. Woyshner
District Director

cc: Robert Aman, Partner
(Same address)

 

-

3TP LLC 05-Oct-04

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Center for Devices and Radiological Health 2098 Gaither Road Rockville, MD 20850

OCT 5 2004

WARNING LETTER

VIA FEDERAL EXPRESS
VIA FACSIMILE

Mr. Jordan Metzgar
3TP LLC
33 Flying Point Rd. Suite 217
Southampton, New York 11968

Re: 3TP Software, K031350

Dear Mr. Metzgar:

The Diagnostic Devices Branch (DDB), Office of Compliance (OC), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) has reviewed your Internet website for 3TP Software. Based on our review of your website, it appears that your company is marketing 3TP Software for intended uses beyond the scope of your FDA clearance for the product.

3TP Software is a device as defined within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) 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 because it is intended to affect the structure or any function of the body.

FDA cleared 3TP Software for the following indications:

The 3TP Software Option is intended to be used as a post processing software package designed to provide a reliable means for visualizing the presence and pattern of contrast induced enhancement on MR datasets. 3TP supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The resulting time course information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained physician the information provided by the 3TP Software Option could yield information that may assist in the interpretation of dynamic contrast enhanced studies.

Your website, http://vclassroom.hyperion.com, demonstrates that 3TP LLC is marketing the 3TP Software for intended uses that do not fall within the existing clearance. For instance, the website states that 3TP Software “facilitates rapid detection of breast cancer.”

Other items on the website that go beyond your FDA clearance include:

• “There are various methods of detecting cancer using MRI technology, however, the patented 3TP technique is the only one that provides an accurate, scientific based standardized system.”
• “3TP is an innovative software solution that facilitates detection of breast cancer through rapid interpretation of contrast enhanced MRI images.”

Marketing the 3TP Software for indications beyond the scope of your FDA clearance violates the law. Specifically, the device is adulterated under section 501(f)(1)(B) of the Act because you do not have an approved Premarket Approval Application (PMA) to demonstrate that the device is safe and effective for the new intended uses for which you are marketing it. In addition, your device is misbranded under section 502(o) of the Act because you have not submitted a section 510(k) premarket notification to notify the agency of your intent to introduce the device into commercial distribution for these new intended uses. For a product requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the FDA. [21 CFR 807.81(b).]

This letter is not intended to be an all-inclusive list of deficiencies associated with your device. It is your responsibility to ensure adherence to each requirement of the Act and Federal regulations. You are responsible for investigating and reviewing these materials to assure compliance with applicable regulations.

You should take prompt action to correct these violations. Failure promptly to correct these deviations may result in regulatory action against your company being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Also, federal agencies are informed about warning letters we issue, such as this one, so that they may consider this information when awarding government contracts.

Please notify this office, in writing, within 15 working days of receipt of this letter, outlining the specific steps you have taken to correct the cited violations. Your response should also include all steps being taken to address misleading information currently in the market place and actions to prevent similar violations in the future. 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 Mr. William C. Maloney, Physicist, Diagnostic Devices Branch (HFZ-322), at the letterhead address.

Sincerely yours,

/s/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

-

Warning Letter Response

• 3TP, LLC Response Letter

-

-

Aap Implantate AG 16-Jul-04

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Center for Devices and Radiological Health 2098 Gaither Road Rockville, MD 20850

WARNING LETTER

VIA FEDERAL EXPRESS

JUL 16 2004

Mr. Uwe Ahrens
CEO
Aap Implantate AG
Lorenzweg 5
12099 Berlin, Germany

Dear Mr. Ahrens:

During the inspection of your firm located in Berlin, Germany on January 26-29, 2004, United States Food and Drug Administration (FDA) investigator, James P. Mcreavey,
determined that your firm manufactures labeled non-sterile Class I and labeled non-sterile Class II orthopedic implants. Additionally, your firm has a current 510(k) under review for a labeled sterile Class II orthopedic implant. These products are devices within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(h)].

The investigator documented significant violations from the Quality System (QS) regulation Title 21, Code of Federal Regulations (CFR), Part 820. These violations cause the devices listed above to be 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 established by the QS regulation.

Your firm’s significant violations include, but are not limited to, the following:

1. Failure to establish and maintain adequate design input procedures, as required by 21 CFR 820.30(c), Design Input.

The QS regulation under 21 CFR 820.30(c) requires the Design Input procedures to include a mechanism for addressing incomplete, ambiguous, or conflicting requirements.

Your firm failed to comply with the requirements of 21 CFR 820.30(c). For example, your design control procedures for the knee endoprosthesis device lack a mechanism for addressing incomplete, ambiguous or conflicting design input requirements. FDA acknowledges receipt of your firm’s March 05, 2004 response to the FDA Form 483 observations. In the response, your firm promised to provide a revised procedure by March 2004. To date, we have not received any correspondence from your firm with the promised correction. Please supply the revised procedure.

2. Failure to adequately maintain device master records, as required by 21 CFR 820.181, Device Master Record (DMR).

The regulation under 21 CFR 820.181 requires that the DMR for each type of device shall include, or refer to the location of, the following information: device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications and installation, maintenance and serving procedures and methods.

Your firm failed to comply with the requirements of 21 CFR 820.181. For example, the knee endoprosthesis DMR did not contain or reference (1) device drawings, (2) equipment specifications for the Roders machine used to manufacture the device, and (3) packaging and labeling specifications.

FDA acknowledges that these deficiencies were corrected by your firm and verified at the close-out of the inspection by the investigator. You appear to have adequately corrected this quality problem. Please explain how your firm intends to ensure that this kind of quality problem is not repeated.

3. Failure to validate, according to an established protocol, computer software for its intended use, when that software is used as part of the Quality System or part of production as required by 21 CFR 820.70(i), Automated Processes.

The regulation under 21 CFR 820.70(i) requires that when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.

Your firm failed to comply with the requirements of 21 CFR 820.70(i). For example:

(1) The [redacted] software used in the design and development process is not validated.
(2) The [redacted] program used by the [redacted] machine has not been validated for its intended use.
(3) The [redacted] software used for inventory and process control has not been validated for its intended use.

The March 05, 2004 response indicates that your firm would provide the missing validation information for the [redacted] software programs by July 2004. The response is not adequate. Please provide the software validation protocols for these three software programs and explain how your firm plans to prevent this error from recurring in the future.

4. Failure to establish and maintain a Design History File for each type of device as required by 21 CFR 820.30(j), Design History File (DHF).

The regulation under 21 CFR 820.30(j) requires that each manufacturer shall establish and maintain a DHF for each type of device.

You failed to comply with the requirements of 21 CFR 820.30(j). For example, there is no DHF for the knee endoprosthesis device. Your firm’s response dated March 05, 2004 promises correction by July 2004 and states your R&D manager has begun to provide the DHF and it should be completed and sent before the promised date. This is not an adequate response. Please provide a copy of the DHF for the knee endoprosthesis device, a copy of the procedure(s) your firm utilizes for assembling the DHF to fulfill the requirements of 820.30(j), and explain how your company plans to ensure this error is not repeated.

FDA also wishes to address a potential design verification violation. Although FDA acknowledges that your firm’s knee endoprosthesis has not yet been marketed in the USA and that all design control activities related to this device may not have been completed, at the time of the inspection your firm lacked documentation establishing that [redacted] sterilization of the [redacted] packaging did not impact on the performance of the [redacted] packaging. This observation was noted on the List of Inspectional Observations (Form FDA 483) issued at the closeout of the inspection.

FDA acknowledges that the investigator annotated this Form FDA 483 observation as Corrected and Verified. Additionally, your response, dated March 05, 2004, states that the certification from the supplier which assures that materials could be used for [redacted] sterilization has been integrated into the Device Master Record (DMR). The verification by the investigator and the response from your firm appear to be adequate. However, please take note that if your firm had not corrected this problem before marketing the device in the United States, it would have resulted in a failure to adequately document all design verification activities establishing that Design Outputs meet the Design Input requirements as required by 21 CFR 820.30(f), Design Verification.

This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure adherence to each requirement of the Act and applicable regulations. The specific violations noted in this letter and Form FDA 483 issued at the closeout of the inspection may be symptomatic of serious underlying problems in your firm’s manufacturing and quality assurance systems.

U.S. 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 government contracts.

Given the serious nature of these violations of the Act, the various orthopedic implants manufactured by your firm imported or offered for import are subject to refusal of admission under section 801 (a) of the Act, 21 U.S.C. 381 (a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as “detained without physical examination,” until these violations are corrected. In order to prevent your devices from being detained without physical examination, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.

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. You should include all documentation of the corrective action you have already taken. If you plan to make any corrections in the future, include those plans with your response to this letter as well. If the documentation is not in English, please provide a translation to facilitate our review.

Your response should be sent to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Enforcement B, Orthopedic, Physical Medicine and Anesthesiology Devices Branch, 2094 Gaither Road, Rockville, Maryland 20850 USA, to the attention of Ms. Christy Foreman.

If you need help in understanding the contents of this letter, please contact Ms. Christy Foreman at the above address, or at (301) 594-4659 (telephone) or (301) 594-4672 (telefax).

Sincerely yours,

/s/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

-