Zander Scientific, Inc. DBA Zander IVF, Inc.

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Florida District 555 Winderley Place, Suite 200 Maitland, Florida 32751 Telephone: 407-475-4700 FAX: 407-475-4770

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
FLA-11-03
 

October 5, 2010
 

Friedel M. Zander
President and COO
Zander Scientific, Inc. dba Zander IVF, Inc.
755 8th Court, Suite 4
Vero Beach, Florida 32965-0790

Dear Mr. Zander:

During an inspection of your firm located in Vero Beach, Florida on July 12, 2010 through July 14, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of the zIVF-AIRe™ 100C Photo-Catalytic Air Purifier. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a medical 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.

This inspection revealed that this device is 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, 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 Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from you dated July 22, 2010, concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1).

For example, you have no written design control procedures for the zIVF-AIRe™ 100C Photo-Catalytic Air Purifier including not having documentation of labeling requirements.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR 820.30(a)(1) nor have you informed us of any specific plan or provided evidence of immediate corrections and systemic corrective actions. Your firm has not provided written design control procedures and documentation of labeling requirements for the zIVF-AIRe™ 100C Photo-Catalytic Air Purifier.

2. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).

For example, you do not have a written corrective and preventive action procedure.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR 820.100(a) nor have you informed us of any specific plan or provided evidence of immediate corrections and systemic corrective actions. Your firm has not provided a written corrective and preventive action procedure.

3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints and failure to maintain complaint files, as required by 21 CFR 820.198(a).

For example, you do not have a written complaint procedure nor do you maintain complaint files for the complaints stated to the FDA investigator that your firm received concerning the zIVF-AIRe™ 100C Photo-Catalytic Air Purifier.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR 820.198(a) nor have you identified any systemic corrective actions regarding the lack of procedures for the receipt, review, and evaluation of complaints by a formally designated unit. Your firm has not provided a written complaint procedure nor have you provided complaint files for the complaints stated to the FDA investigator that you received concerning the zIVF-AIRe™ 100C Photo-Catalytic Air Purifier.

4. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.

For example, you have no written procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR 820.50 nor have you informed us of any specific plan or provided evidence of immediate corrections and systemic corrective actions including what controls are applied to existing suppliers. Your firm has not provided written procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

5. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

For example, your firm lacks written internal audit procedures and has not documented any internal audit activities.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR 820.22 nor have you informed us of any specific plan or provided evidence of immediate corrections and systemic corrective actions. Your firm has not provided written internal audit procedures and documentation of any internal audit activities.

6. Failure to ensure that management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals,as required by 21 CFR 820.20(c).

For example, your firm lacks written management review procedures and you stated to the FDA investigator that you have not documented any management review meetings concerning the zIVF-AIRe™ 100C Photo-Catalytic Air Purifier.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR 820.20(c) nor have you informed us of any specific plan or provided evidence of immediate corrections and systemic corrective actions. The response also does not state that your quality system would be reviewed to ensure that your quality system satisfies the requirements of 21 CFR 820 and specific quality objectives. Your firm has not provided written management review procedures and documentation of any management review meetings concerning the quality system used to design and develop the zIVF-AIRe™ 100C Photo-Catalytic Air Purifier.

This inspection also revealed that your device is 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 or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:

Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.

For example, you do not have written MDR procedures.

We have reviewed your response and have concluded that it is inadequate because you have not addressed the regulatory requirements to develop, maintain and implement written MDR procedures.

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 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 actions 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: Salvatore N. Randazzo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact Mr. Randazzo at (407) 475-4712.

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 (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 and to bring your products into compliance.
 

Sincerely yours,
/S/
Emma R. Singleton
Director, Florida District
 

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