Inspections, Compliance, Enforcement, and Criminal Investigations
Panbio, Inc. 05-Oct-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Baltimore District Office |
6000 Metro Drive, Ste 101
Baltimore, MD 21215-3215
Telephone: (410) 773-5454
October 5, 2005
RETURN RECEIPT REOEUSTED
Mr. Carl S . Stubbings
Senior Vice President
9075 Guilford Road
Columbia, MD 21046
Dear Mr. Stubbings:
We are writing to you because on May 4, 2005, the Food and Drug Administration (FDA) conducted an inspection of your establishment located at 9075 Guilford Rd, Columbia, MD, which revealed a serious regulatory problem involving the: Human Herpesvirus 6 IgM and IgG IFA Kits distributed by your firm.
Under a United States law, section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), this product is considered to be a medical device because it is used to diagnose or treat a medical condition, 21 USC 321(h). The law requires, with certain exceptions, that manufacturers of medical devices obtain premarket approval or marketing; clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that newly introduced medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.
The devices you are selling are test kits. Panbio's catalog describes the products as test kits, customers order them as test kits, and package labeling inserts available on Panbio's web site describe the products as kits, provide instructions for kit use, and make performance claims. While a representative of your firm told the FDA investigator that the products are only offered as kits in your Australian catalog, this Australian catalog, as well as the product inserts, are accessible to United States customers through your web site and U.S. customers have ordered the test kits. This is evident from sales documentation and the affidavit from your firm, which document that orders for the HHV 6 IgM and IgG Kits, catalog numbers IHV601M, and IHV601G have been received and filled by your firm for U.S. customers. Our records do not show that you obtained marketing clearance before you began offering your product for sale. As a result, the Human Herpesvirus 6 IgM and IgG IFA Kits are adulterated under section 501 (f)(1)(13) [21U.S.C. 351(f)(1)(B)] of the Federal Food Drug and Cosmetic Act (the Act), in that they are class III devices under section 513(f) and do not have an approved application for premarket approval in effect pursuant to section 515(a) or an approved application for investigational device exemption under section 520(g). These devices are also misbranded under section 502(o) [21U.S.C. 352(o)], because a notice or other information respecting them was not provided to the FDA as required by section 510(k). For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application is pending before the agency, 21 CFR 807.81(b).
Review of your product catalog raises additional concerns with regard to your products listed as ELISA Analyte Specific Reagents (ASRs) and products listed as IFA components. It appears that the products identified as ASRs are assays and not ASRs. See 21 CFR 864.4020(a). Similarly, it appears that the products described on your website as IFA components, specifically the HHV 6 IFA Slides, may 'be finished devices rather than components of devices. See 21 CFR 820.3(c). If these components are finished devices intended for in vitro diagnostic use then they should be labeled as such and must satisfy any applicable regulatory requirements.
This letter is not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and the regulations. The specific violations noted in this letter may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions.
In addition, 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. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in the initiation of regulatory action by the FDA without further notice. These actions include, but are not limited to, seizure of your product inventory, obtaining a court injunction against the further marketing of the product, or assessing civil money penalties.
Please provide this office in writiing, within 15 working days of receipt of this letter, a report of the specific steps you have taken, or will take to identify and correct these problems and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Your reply should be directed to Steven B. Barber, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD 21215.
Michael W. Roosevelt
Acting District Director