WARNING LETTER
Health-Chem Diagnostics, LLC MARCS-CMS 526232 —
- Recipient:
-
Recipient NameJack L. Aronowitz
- Health-Chem Diagnostics, LLC
3341 SW 15th Street
Pompano Beach, 33069
United States
- Issuing Office:
- Florida District Office
United States
Office of Medical Device and Radiological Health Operations (OMDRHO) | |
WARNING LETTER
CMS# 526232
UNITED PARCEL SERVICE
w/DELIVERY CONFIRMATION
December 7, 2017
Jack L. Aronowitz, President
Health-Chem Diagnostics, LLC
Division of P & L Development, LLC
3341 SW 15th Street
Pompano Beach, FL 33069
Dear Mr. Aronowitz:
During an inspection of your firm, Health-Chem Diagnostics, LLC, located in Pompano Beach, Florida,on January 2, 2017, through February 3, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures in vitro diagnostic tests including, but not limited to, tests for pregnancy and Zika virus. 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.
In addition, the inspection also revealed your One-Step Test for Zika Virus Antibody and One-Step Test for Zika Virus IgG/IgM Antibody tests are 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 devices do not have an approved PMA, or an Emergency Use Authorization in effect pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3. The devices are 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). For a device 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)].
Your firm should take prompt action to correct the violation 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 (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.
If you have questions regarding any issues in this letter, please contact Compliance Officer, Andrea H. Norwood at 407-475-4724 or at Andrea.Norwood@fda.hhs.gov. Please send your reply electronically to Blake Bevill, Director of Compliance Branch, oradevices2firmresponse@fda.hhs.gov.
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 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.
Sincerely,
/S/
Kathleen M. Sinninger
Acting Program Division Director
Office of Medical Device and Radiological Health
Division 2 – Central