Inspections, Compliance, Enforcement, and Criminal Investigations
Sun Biomedical Laboratories, Inc. 12-Apr-07
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
| Waterview Corporate Center |
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4906
April 12, 2007
RETURN RECEIPT REQUESTED
Ming Sun, M.D.
President & Chief Executive Officer
Sun Biomedical Laboratories, Inc.
604 VPR Center
1001 Lower Landing Road
Blackwood, NJ 08012
Dear Dr. Sun:
During an inspection of your establishment located at 1001 Lower Landing Road, Blackwood, New Jersey, from April 3 until April 10, 2006, an Investigator from the Food and Drug Administration (FDA) determined that your firm manufactures and distributes VisuaLine® Propoxyphene Dip One Step Drug Screening Test, VisuaLine® Oxycodone Dip One Step Drug Screening Test, VisuaLine® TCA Dip One Step Drug Screening Test, OraLine® IV Saliva Drug Screen Test, and AlcoStat™ One Step/Saliva or Urine Alcohol Screening Test kits. Under a United States law, the Federal Food, Drug, and Cosmetic Act (the Act), products are considered to be devices as defined by Section 201(h) of the Act (21 U.S.C. 321(h)) if they are intended for use in the cure, mitigation, treatment, or prevention of disease, or in the diagnosis of disease or other conditions. We note that your products are intended for use in the diagnosis of disease, such as alcoholism, and conditions, such as intoxication.
At the close of the inspection, the FDA Investigator discussed with you the Form FDA 483 on which she noted objectionable conditions observed during the inspection. On May 4, 2006, your firm provided a written response to the Form FDA-483 issued by the Investigator. The violations revealed as a result of the inspection and your response are discussed below.
The Act requires that manufacturers of medical devices obtain marketing clearance or approval for their products from FDA before they may offer them for sale. This helps protect the public health by ensuring that new medical devices are shown to be either safe and effective or substantially equivalent to other devices already legally marketed in this country.
A review of our records has determined that your firm did not obtain clearance or approval from FDA before you began marketing any of the aforementioned tests. Marketing tests kits that are devices without clearance or approval from FDA is a violation of the law. In legal terms, such devices are misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) and adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)). Your devices are misbranded under the Act because you did not submit a premarket notification under section 510(k) of the Act (21 U.S.C. § 360(k)). Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that your devices are substantially equivalent to other legally marketed devices, your devices are also adulterated under the Act because the law requires, and you do not have, an approved premarket approval application that shows your devices are safe and effective. 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 (PMA) is pending before the agency. 21 CFR 807.81(b).
It is your firm's responsibility to establish compliance with the requirements for premarket clearance or approval by making appropriate premarket submissions. The kind of information you will need to submit in order to obtain approval or clearance is described on FDA's device web site at www.fda.gov/cdrh/devadvice. FDA will evaluate this information and decide whether your products may be legally marketed.
The FDA inspection also revealed that these devices are adulterated under 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 conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System (QS) regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:
1. Failure to adequately validate and approve according to established procedures a process whose results cannot be fully verified by subsequent inspection and test as required by 21 CFR § 820.75. Specifically, your firm failed as of the time of this inspection to adequately validate your use of the, [redacted] (a new piece of equipment) used during the [redacted] which is used for your drug screening and pregnancy test kits. Your firm evaluated one lot of product (OraLine d-Meth RAB lot [redacted] and did not demonstrate that your process will consistently produce a product which will meet all specified requirements.
2. Failure to establish adequate quality requirements that must be met by suppliers as required by 21 CFR § 820.50(a): Specifically, your firm purchased, provided instructions for use, and subsequently distributed products without establishing adequate quality requirements for such suppliers and products. For example:
A) Your firm received BreathScan Alcohol Detectors from [redacted] applied labeling, and distributed them without evaluating the capability of your supplier to provide your firm with acceptable product.
B) Your firm received AlcoStat Alcohol Test Kits from [redacted] inserted your instructions for use, and distributed them without evaluating the capability of your supplier to provide your firm with acceptable product.
You should know that these are serious violations of the law. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice to you. These actions include, but are not limited to, seizure, injunction and/or civil monetary penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering awards of contracts. Additionally, premarket approval applications for class III devices to which Quality System regulation deviations 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.
FDA has received your written response, dated May 4, 2006, to the Form FDA-483 that was issued to you at the end of the inspection. This response, however, does not establish that you have adequately corrected your violations of the Act. In particular, your responses to FDA-483 observations one and two do not specify if the qualification batches for your [redacted] of test [redacted] met your specified requirements. For example, your firm made changes to your [redacted] without specifying in your [redacted] Procedure what the range should be for the [redacted] of the [redacted] the [redacted] In addition, your response to observation three does not provide us with any assurance that your suppliers will be able to provide your firm with acceptable product. Furthermore, your response does not discuss what your corrective actions (promised during the inspection) will be concerning the distribution of unapproved devices by your firm.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and on the Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems within your establishment's quality system. 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 and preventive actions.
Please notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.
Your written response to this Warning Letter should be directed to the New Jersey District, FDA, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054, Attn: Robert J. Maffei, Compliance Officer. If you have any questions concerning the contents of this letter, you may contact Mr. Maffei by telephone at 973-331-4906, or by email at Robert.Maffei@fda.hhs.gov.
Douglas I. Ellsworth
New Jersey District