| Public Health Service Food and Drug Administration |
Waterview Corporate Center |
Department of Health and Human Services
July 12, 2011
VIA UNITED PARCEL SERVICE
WARNING LETTER
Mr. Tim Fegan
President
Peace Medical, Inc.
50 South Center Street, Suite 11
Orange, New Jersey, 07050-3530
11-NWJ-20
Dear Mr. Fegan:
During an inspection of your firm located in Orange, New Jersey, on March 29, 2011, through April 5, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Demistifier Isolation Chamber Models 2000B & 2000C; and Demistifier Ambulance Transport Isolation System Model 2700. 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.
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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
These violations include, but are not limited to, the following:
1. Failure to establish 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). For example, your firm manufactured and sold Demistifier Ambulance Transport Isolation System Model 2700 on January 1, 2007.
However, your firm was unable to provide any established design control procedures or a design history file related to Model 2700 device.
2. Failure to adequately establish and maintain procedure for implementing corrective and preventive action, as required by 21 CFR 820.100. For example, during the inspection, the firm drafted and provided procedure, SOP Corrective and Preventive Action, to fulfill the requirements of 21 CFR 820.100. However, the procedure does not provide any details as to how potential nonconformities will be identified, how nonconformities will be investigated, how actions needed to correct and prevent recurrence of nonconformities will be identified, how such actions will be verified and validated, how changes in methods and procedures needed to correct and prevent identified quality problems will be implemented and recorded, and how information will be disseminated to responsible people and for management review.
3. Failure to maintain device master records (DMR), as required by 21 CFR 820.181. For example, your firm manufactured and sold Demistifier Ambulance Transport Isolation System Model 2700 on January 1,2007. However, your firm was unable to provide any established DMR for Model 2700 device.
4. Failure to maintain device history record (DHR) to demonstrate that the device is manufactured in accordance with the device master record (DMR), as required by 21 CFR 820.184. For example, your firm manufactured and sold Demistifier Ambulance Transport Isolation System Model 2700 on January 1, 2007. However, your firm was unable to provide any DHR for the distributed device.
Our inspection (also) revealed that your 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 (MDR) regulation. Significant violations include, but are not limited to, the following:
Failure to have an internal system that provides for timely and effective identification, communication and evaluation of events that may be subject to MDR requirements, a standardized review process for determining when an event meets the criteria for reporting, and timely transmission of complete medical device reports, as required by 21 CFR §803.17(a).
For example:
1. Your firm's procedure does not describe how you will obtain information, such as patient follow-up information, that may be needed in order to conduct a proper evaluation of an event that may be subject to MDR requirements.
2. Your firm's criteria for determining when an event should be reported to FDA includes "if at any time a manufacturer or importer may become aware of such information...that an event has occurred that may have caused or contributed to a death or serious injury or, has malfunctioned and if the malfunction recurs is likely to cause or contribute to a death or serious injury." When determining when an event meets the criteria for reporting, your firm must consider that it has "become aware" whenever any employee receives or otherwise becomes aware of information that reasonably suggests that one of your firms marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and that the device or a similar device marketed by your firm would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
3. Your firm's procedure does not include the mailing address for submission of MDRs to FDA. A manufacturer must submit any written reports or additional information to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002 as required by 21 CFR Part 803.12(a). Failure to comply with this requirement can result in failure to submit complete medical, device reports to FDA in a timely manner.
4. The procedure titled "Medical Device Complaint-MDR Event" states that a report "shall be submitted to the FDA by telephone ... a telephone report must be followed by a written report." A manufacturer must submit all reports of individual adverse events on FDA MEDWATCH Form 3500A or in an electronic equivalent as approved under 803.14 as required by 21 CFR Part 803.11. Failure to comply with this requirement can result in a failure to submit complete reports to FDA in a timely manner.
Our inspection also revealed that the 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). The device is also misbranded under section 502(0) of 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 CFR 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.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (section 510(p) of the Act (21 U.S.C. 360(p))) during the period beginning October 1st and ending December 31 st of each year. Our records indicate that you have not fulfilled your annual registration and listing requirements for fiscal year 2011.
Therefore all of your devices are misbranded within the meaning of section 502(0) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 (21 U.S.C. § 360) and were not included in a list required by section 5100) (21 U.S.C. § 360(j)).
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
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. 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 you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this warning letter.
Your response should be sent to New Jersey District Office. Refer to the Unique Identification Number 181412 when replying. If you have any questions about the content of this letter please contact: Ms. Stephanie Durso, Compliance Officer, New Jersey District Office, via phone at (973) 331-4911 or via fax at (973) 331-4969.
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 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 management 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/
Diana Amador-Toro
District Director
New Jersey District
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