Inspections, Compliance, Enforcement, and Criminal Investigations
Human Biosciences, Inc. 5/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Baltimore District Office|
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705
RETURNED RECEIPT REQUESTED
May 10, 2012
Dr. Manoj K. Jain
Chief Executive Officer
Human Biosciences, Inc.
940 Clopper Rd
Gaithersburg, Maryland 20878
Dear Dr. Jain,
During an inspection of your firm located in Gaithersburg,Maryland,on September 7, 2011, through October 18, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures SkinTemp II wound dressings. 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 any function of the body.
A review of our records indicates that SkinTemp was cleared under 510(k) number K913023 with the intended use as a wound dressing for burns, blisters, scrapes, and cuts. A modification to K913023 was submitted and cleared under 510(k) number K925545 with intended use in the management of burns, sores, blisters, scrapes, ulcers, and other wounds. The clearance letter associated with the listed 510(k)s states the following:
- This device may not be labeled for use on third degree bums.
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound.
The letter also states that the labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The FDA reviewed your firm’s brochure, Kollagen Technology featuring Medifil II and SkinTemp II, and determined that it contained the following claims:
· “Fibrillar Collagen Helps in Every Phase of Wound Management”
· “Hemostasis (stops bleeding)”
· “Wound Debridement (cleanses the wound)”
· “Granulation & Angiogenesis (establishes new tissue and blood vessels)”
· “Fibroblastic activity (creates structural matrix)”
· “Re-epithelialization (closes the wound)”
· “Wound Remodeling (regains original integrity)”
· “Activate the healing process with Kollagen”
In addition to your firm’s brochure, FDA reviewed your firm’s website (www.humanbiosciences.com), for SkinTemp II Sheets on April 13, 2012, and determined that your firm is marketing the device as follows:
“Collagen is known to have antimicrobial properties; hence SkinTemp II dressings help prevent microbial infection . . . . The triple helical structure also promotes the growth of fibro-vascular tissue and reduces the loss of water, electrolyte, and heat from the wound.”
These claims represent a major change in the intended use of the device. Therefore SkinTemp II 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), in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
During the inspection, FDA also learned that SkinTemp II contains an ingredient identified as (b)(4).” A review of our records shows no clearance or approval for your firm's SkinTemp II device with (b)(4)” Therefore, SkinTemp II is further misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), in that a notice or other information respecting the modification of the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i).
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)] 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/cdrh/devadvice/3122.html. 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.
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: Evelyn Bonnin District Director, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, MD, 21215. Refer to the CMS case # 281637 when replying. If you have any questions about the contents of this letter, please contact: CDR Rochelle B. Young at 410-779-5437 or Fax at 410-779-5705.
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.
Baltimore District Director