- Rapid Diagnostics, Division Of Mp Biomedicals, Llc
- Issuing Office:
- San Francisco District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
August 24, 2015
VIA UNITED PARCEL SERVICE
Milan Panic, CEO
Rapid Diagnostics, Division of MP Biomedicals, Llc
1429 Rollins Road
Burlingame, CA 94010-2316
Dear Mr. Panic:
During an inspection of your firm located in Burlingame, California between February 19 and March 2, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures in vitro diagnostic devices including the OneStep Myoglobin RapidCard InstaTest. 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 function of the body.
This inspection revealed that the OneStep Myoglobin RapidCard InstaTest device is 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 OneStep Myoglobin RapidCard InstaTest device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution in that a notice or other information regarding the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 C.F.R. 807.81(a)(3)(ii). 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. 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.
In addition, 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 Amendment 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 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2015. Specifically you have not listed devices manufactured, prepared, propagated, compounded, or processed in your establishment, including OneStep Myoglobin RapidCard InstaTest, Troponin I Serum/Whole Blood RapidCard InstaTest, Fecal Occult Blood Test Card and RapidPSA Test. Therefore all of your firm’s devices that are not currently listed are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(o)0, in that the devices were manufactured , prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
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.
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 (which must address systemic problems) 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: Lawton W. Lum, Director of Compliance at 1431 Harbor Bay Parkway, Alameda, CA 94502. Refer to the Unique Identification Number 441322 when replying. If you have any questions about the contents of this letter, please contact: Sergio Chavez, Compliance Officer at (510) 337-6886 or (510) 337-6703 fax.
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 Inspectional 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.
Kathleen M. Lewis, J.D.
Director, San Francisco District
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