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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Noble Anesthesia-Air, Inc. 9/12/12

  

Department of Health and Human Services' logoDepartment 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: 407-475-4769

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-12-45

September 12, 2012
 

James P. Noble, M.D.
General Manager and Owner
Noble Anesthesia-Air, Inc.
4637 NW 6th St
Gainesville, Florida 32609


Dear Dr. Noble:

During an inspection of your firm located in Gainesville, Florida, on June 19, 2012, through June 26, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Adult SNOR-TAL, the SNOR-SCOPE, the SNOR-PAC, the SNOR-CAL and the SNOR-SCOPE PLUS. 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 to affect the structure or any 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from you dated July 16, 2012, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, which was issued to your firm. 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, your firm's quality consultant, (b)(6) stated that there are no design control procedures in place at Noble Anesthesia-Air Inc. 

We reviewed your firm's response and conclude that it is not adequate. Your firm states that it will write a Design Control Standard Operating Procedure (SOP) and supporting documentation based on 21 CFR 820 by August 3, 2012. Your firm has not submitted any documentation or evidence of implementation of corrections and corrective actions that addresses the observed deficiency.

2. Failure to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The design input requirements shall be documented and shall be reviewed and approved by a designated individual, as required by 21 CFR 820.30(c).

For example, the design inputs requirements have not been reviewed or approved by a designated individual in the firm. The design input document for the SNOR-TAL device was not signed to document review and approval of the design inputs.

Your firm's response did not address this deficiency.

3. Failure to establish and maintain adequate procedures for verifying device design to confirm that the design output meets the design input requirements.

The results of the design verification, including identification of the design, methods, the date, and the individuals performing the verification, shall be documented in the design history file (DHF), as required by 21 CFR 820.30(f).

For example, your firm did not adequately document the results of the design verification in the DHF for Validation #VAL0-050. Seal integrity testing of product as required by Workstep #0-073 was only performed on 59 of 60 pouches.

Your firm's response did not address this deficiency.

4. Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses, that proper risk analysis is completed, and that the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation, are documented in the design history file, as required by 21 CFR 820.30(g).

For example, you provided a letter that you wrote to the quality consultant describing the use of the device in anesthesia-related procedures as an example of validation that you performed. This is inadequate to meet this requirement.

Your firm's response did not address this deficiency.

5. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h).

For example, your firm does not have procedures for design transfer to ensure that device design is correctly translated into product specifications.
Your firm's quality consultant stated that the transfer of the design to production was not documented.

Your firm's response did not address this deficiency.

6. Failure to establish and maintain a DHF for each type of device to demonstrate that the design was developed in accordance with the approved design plan and design control requirements, as required by 21 CFR 820.300).

For example, you firm's quality consultant stated that the firm does not have a DHF for the SNOR-SCOPE Plus, a Class II device with a 510(k).

Your firm's response did not address this deficiency.

7. Failure to establish and maintain adequate requirements, including quality requirements, that must be met by suppliers, contractors, and consultants.
Each manufacturer shall define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results, as required by 21 CFR 820.50(a)(2).

For example, your firm's "Purchasing" document, NAFA-001, Revision A, effective March 19, 2012, does not define the type and extent of control to be exercised over the services and products provided by the firm's suppliers and contract manufacturers, nor does it refer to other SOPs or documents that may define these requirements.

We reviewed your firm's response and conclude that it is not adequate. Your firm states that it will revise and update its contract with (b)(4) to identify responsibilities, requirements, and product specifications by August 24, 2012. Your firm has not submitted documentation or evidence of implementation of the contract with (b)(4) or described the types and extent of control its suppliers and contract manufacturers will be exercising over products and services.

8. Failure to maintain complaint files and establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

For example, your firm's "Complain/CAPA" document, NAQA-002, Revision A, effective June 27, 2011, does not include an established mechanism for receiving, reviewing, and evaluating all complaints by a formally designated unit. Specifically, the complaint procedures specify that complaints are handled by "Quality Control Department and/or Operations Manager" of Noble Anesthesia-Air; however, your firm's consultants stated that the firm does not have a formal Quality Control department.

We reviewed your firm's response and conclude that it is not adequate. Your firm states it will revise Complain/CAPA SOP, NAQA-002 by July 27, 2012; however, your firm has not submitted evidence of any corrections or corrective actions nor has it provided evidence of implementation of revised procedures

9. Failure to establish and maintain adequate 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's "internal audit" document, NAQA-01 0, Revision A, effective June 27, 2011, does not include a requirement for coverage of quality system regulation areas including, but not limited to, complaint handling/files and medical device reporting (MDR).

We reviewed your firm's response and conclude that it is not adequate. Your firm states that Internal Audit SOP and Internal Audit Report, (b)(4) and (b)(4) to include the quality system areas and review requirements for compliance, by July 27, 2012. Your firm's response is not adequate because it did not include documentation of these changes.

Our inspection also revealed that your firm's devices 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 or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

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

For example, after reviewing your firm's MDR procedure titled, "MDR-Medical Device Reporting," Document Number NAQA-004, Revision A, dated June 27, 2011, the following issues were noted:

(1) NAQA-004 does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements.

For example, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 of the terms "caused or contributed," "malfunction," "MDR reportable event," and "serious injury," and definitions of the terms "reasonably known" and "reasonably suggests," found respectively in 21 CFR 803.50(b) and 803.20(c)(1).

(2) NAQA-004 does not establish internal systems that provide a standardized review process to determine when an event meets the criteria for reporting under this part. For example:

• There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.

• There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.

(3) NAQA-004 does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:

• Instructions for how to complete the FDA 3500A form;

• Instructions for how to obtain the FDA 3500A form;

• Circumstances under which an event must be submitted as a 30-calendar day and 5-day report;

• How your firm will submit all information reasonably known to it for each event;

• The circumstances under which your firm must submit supplemental or follow-up report and the requirements for such reports; and

• The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. 0. Box 3002, Rockville, MD 20847-3002.

(4) NAQA-004 does not describe how your firm will address documentation and record-keeping requirements, including:

• Information that was evaluated to determine if an event was reportable;

• Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable; and

• Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.

The adequacy of your firm's response cannot be determined at this time. Your firm stated that it projects completion of revisions to the MDR procedure by August 17, 2012. A copy of the revised procedure was not included in the response.

Your firm's procedure includes references to Baseline Reporting and Annual Certification. The requirement for Baseline Reporting was removed under the Direct Final Rule, effective October 27, 2008. The requirement for Annual Certification was repealed under the FDA Modernization Act, effective February 19, 1998. We recommend that all references to Baseline Reporting and Annual Certification be removed from your firm's MDR procedure.

Our inspection also revealed that the Adult SNOR-TAL is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

The Adult SNOR-TAL labeling states that the device may be used as a tool to facilitate the induction of anesthesia and that it may be used during controlled ventilation. Although you told our investigator that this device is a Class I medical device, no such device classification exists for the uses described in the device labeling. Hence either clearance under section 510(k) of the Act or approval of a PMA is required for this device, and you have no such clearance or approval. For a d evice requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81 (b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicaiDevices/DeviceRegulationandGuidance/HowtoMarkYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.

Your firm's response should be sent to: Carla A. Norris, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. Refer to the Unique Identification Number CMS case# or 328578 when replying. If you have any questions about the contents of this letter, please contact: Ms. Norris at 407-475-4730.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your 'firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the lnspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.

Sincerely,

/S/

Emma R. Singleton·
Director, Florida District