Inspections, Compliance, Enforcement, and Criminal Investigations
Globalemed, LLC 16-Nov-05
Department of Health and Human Services
Public Health Service
Baltimore District Office
November 16, 2005
RETURN RECEIPT REQUESTED
Dr. Ken Peters, President
1101 King Street, Suites 370/270/170
Alexandria, VA 22314-2944
Dear Dr. Peters:
The U.S. Food and Drug Administration (FDA) inspected your establishment located at 1101 King Street, Suites 370/270/170, Alexandria, Virginia, on April 25 and 26, 2005, and June 20, 21, 23, and 27, 2005. Investigators determined that you purchase and distribute in vitro diagnostic (IVD) test kits which are devices within the meaning of section 201(h) [21 U.S.C. 321] of the Federal Food, Drug, and Cosmetic Act (the Act) because they are instruments intended for use in the diagnosis of disease.
The inspection further revealed that you sell and distribute Smart Check HIV 1/2 and Smart Check HBsAg rapid test devices in domestic interstate commerce to missionaries, faith-based organizations, and/or other domestic customers. These rapid test devices are adulterated within the meaning of 501(f)(1)(B) [21 U.S.C. 351(f)(1)(B)] of the Act in that they are class III devices under section 513(f)(1) [21 U.S.C. 360(c)] but do not have approved applications for premarket approval in effect pursuant to section 515(a) [21 U.S.C. 360(e)], or approved applications for investigational device exemptions under section 520(g) [21 U.S.C 360(j)]. The Smart Check HIV 1/2 and Smart Check HBsAg rapid test devices are also misbranded within the meaning of 502(o) of the Act [21 U.S.C. 351(o)] in that a notice or other information respecting the devices was not provided to FDA at least 90 days prior to introduction into interstate commerce as required by section 510(k) of the Act. 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)].
Additionally, the IVD test kits are adulterated within the meaning of section 501(h) [21 U.S.C. 351(h)] of the Act 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 Quality System Regulation (QS Regulation) for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Finished devices were released for distribution before the associated data and documentation were reviewed [21 CFR 820.80(d)(2)]. Specifically, there is no documented review of [redacted] entitled [redacted] (rev. 1, eff. 4/25/04) or other data prior to distribution of products . Your firm uses [redacted] to document labeling activities.
2. The device history records do not include labeling for each device in that the device history records for the rapid test products repacked, labeled, and distributed by your firm did not include the package insert [21 CFR 820.184(e)]. This is a repeat violation from the 2001 inspection, Observation #14.
3. Failure to establish and maintain corrective and preventative action procedures to identify the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problerns [21 CFR 820.100(a)(3)]. Specifically, your complaint handling procedure [redacted] entitled [redacted]. (rev.2, eff. 4/25/04):
A. Does not instruct employees to review the device history records during investigations. Additionally, your firm lacks procedures to address the review of the device history records during investigations;
B. Does not include directions on trending data to identify quality problems. Additionally, your firm lacks procedures to address trending of data to identify quality problems; and
C. Does not address the identification of preventative action based on trended data. Additionally, your firm lacks procedures to address the identification of preventative action based on trended data.
4. Failure to establish and implement procedures to ensure that equipment is routinely calibrated [21 CFR 820.72(a)]. This is a repeat violation from the 2001 inspection, Observation #19. Specifically,
A. Between January 2004 and June 2005, there is no documentation to show that calibration of the meat thermometers used to monitor the Quality Control Laboratory refrigerator has been performed as required by SOP [redacted] entitled [redacted] (rev. 1, eff. 4/25/04)
B. SOP [redacted] entitled [redacted] (rev. 1, eff. 4/25/04), does not address calibration of the meat thermometer used to monitor the temperature of the Quality Control freezer.
5. Unapproved documents were observed being used [21 CFR 820.40(a)]. Specifically, your firm uses data sheets entitled [redacted] and [redacted] to document periodic temperature readings for the QC Laboratory refrigerator and freezer used to store controls for QC testing and retain samples. These forms have not been approved through your firm's document approval process.
6. Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities [21 CFR 820.25(b)]. Specifically, employee [redacted] [redacted]. Manager, responsible for ensuring that your firm is compliant with the QS Regulation and current good manufacturing practice (CGMP) regulations, has not received adequate training. Employees [redacted] has been with your firm since January [redacted].
You may not import these types of devices for export under section 801(d)(3) of the Act [21 U.S.C. 381] under the current circumstances. One of the requirements of that provision is that the importer must submit a statement that the devices will be exported from the United States by the initial owner or consignee in accordance with section 801(e) or 802 of the Act, or section 351(h) of the PHS Act. Given the violations cited above, you may not legally export these devices under any of those three sections. Section 801(e) does not apply because, as explained above, these test kits are class III devices that require premarket approval under section 515 of the Act [21 U.S.C. 360(e)]. Because you do not have premarket approval, section 801(e) does not apply. See Section 801(e)(2)(A).
Also, section 802 does not apply because under section 802(f)(1), importing under section 802 is foreclosed if the device "is not manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice requirements . . . ." As described above, you violate the Quality System Regulation which sets forth current good manufacturing practice requirements for handling those devices. Finally, section 351(h) of the PHS Act does not apply because these devices are not considered to be partially processed biological products. Therefore, the importer may not legally make one of the statements required to import these devices for export under section 801(d)(3). Making such a false statement knowingly is a prohibited act under section 301(w) of the Act.
In addition, we note that the inspection revealed that you are not always exporting these devices, but instead have sold and distributed these devices in domestic interstate commerce. Doing so forecloses your reliance on 801(d)(3) as a legal basis for importing those devices. Moreover, section 301(w) of the Act expressly prohibits releasing devices into domestic interstate commerce that were imported under the import for export provisions of section 801(d)(3).
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 all applicable regulations. The specific violations noted in this letter and in the Form FDA-483 (Inspectional Observations) issued atthe conclusion of the inspection may be symptomatic of serious underlying problems in your establishment's Quality System. You are responsible for investigating and determining the causes of the violations identified by FDA. You must also promptly initiate permanent corrective and preventative action on your Quality System.
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 . No requests for Certificates of Exportability will be issued until the product may be legally exported.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action by FDA without further notice. Such action may include civil penalties, seizure, injunction, and/or refusal of admission of the subject devices.
FDA has reviewed your corrective actions submitted to FDA on July 19, 2005. While it appears from your response that you are working toward correcting the violations noted at your facility, you must implement and maintain each corrective action to ensure its effectiveness.
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: (1) the steps taken to prevent their recurrence; (2) the time within which the corrections will be completed ; (3) any reason the corrective actions have not been completed within the response time; and (4) any documentation necessary to show that corrections have been achieved. Corrective actions addressed in your response to the Form FDA 483 may be referenced in your reply to this letter, as appropriate.
Your reply should be sent to the U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, to the attention of Ms. Vinetta Howard-King, Compliance Officer. Ms. Howard-King can be reached at (410) 779-5413.