Inspections, Compliance, Enforcement, and Criminal Investigations
Stat Medical Devices, Inc.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|555 Winderley Pl., Ste. 200
Maitland, FL 32751
RETURN RECEIPT REQUESTED
April 17, 2009
Stephen S. Schraga, President
Stat Medical Devices, Inc.
2056 Ne 153rd St
Miami, FL 33162-6020
Dear Mr. Schraga:
During an inspection of your firm. located in Miami, Florida on December 1, 2008, through December 3, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer of Stat Super-Fine Insulin Pen Needles, Stat-Let Auto Clinical Safety Lancets, Stat-Let Comfort Thin Lancets, Qwik-Let Lite Lancing Devices, Qwik-Let Ultimate Lancing Devices, and Easy Touch Lancing Devices. 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 function of the body.
This inspection revealed that these devices are adulterated within the meaning of 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 conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from your firm dated February 23, 2009, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you at the close of the inspection. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to adequately implement procedures to control the design of a device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30. For example:
a) Your firm failed to document in the Design History File (DHF) for the Stat Super-Fine Insulin Pen Needle the results of the design verification, including identification of the design, method(s), the date, and the· individual(s) performing the verification, as required by 21 CFR 820.30(1). Specifically,
• You had no documentation of the results of biocompatibility test(s) for the (b)(4) on the Stat Super-Fine Insulin Pen Needles.
b) Your firm failed to document in the DHF of the Stat Super-Fine Insulin Pen Needle the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, as required by 21 CFR 820.30(g). Specifically,
• You had no documentation to demonstrate that the Stat Super-Fine Insulin Pen Needles, which are intended for use with pen injector devices, are compatible with most pen injectors on the market.
c) Your firm failed to include risk analysis in your design validation procedures, as required "where appropriate" by 21 CFR 820.30(g). We have determined that risk analysis is "appropriate" for your devices, and therefore required by 21 CFR 820.30(g), because non-implementation of risk analysis could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action. See 21 CFR 820.1(a)(3). Specifically,
• Your firm's risk analysis for the Stat Super-Fine Insulin Pen Needles did not include analysis of the (b)(4).
2. Failure to validate with a high degree of assurance and approve according to established procedures a process, where the results of that process cannot be fully verified by subsequent inspection and test, and failure to document these validation activities and results, as required by 21 CFR 820.75(a). Specifically,
• Your firm lacks documentation of full ethylene oxide (EO) sterilization validation study regarding its Stat Super-Fine Insulin Pen Needles, as well as documentation of empty chamber studies, calibration of temperature sensors, and biological indicators (BI) enumeration.
• Your firm lacks documentation of full gamma sterilization validation study regarding its Stat-Let Auto Clinical Safety Lances, as well as documentation of dose map and product configuration.
3. Failure to establish and maintain procedures for implementing corrective and preventive actions, including procedures for investigating the cause of nonconformities relating to the product, processes, and the quality system, as required by 21 CFR 820.100(a)(2). Specifically,
• Your firm did not adequately investigate the lancet failure to retract communicated to you in Complaint 07-015 dated November 22, 2007.
4. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1). Specifically, your firm's purchasing controls are inadequate in that:
• Your firm did not evaluate the ability of your supplier (b)(4) to adequately maintain tooling of the Stat-Let Clinical Safety lancets, and your firm did not document whatever evaluation of (b)(4) it did perform.
• Your firm did not document its evaluation of the ability of supplier (b)(4) to meet specified requirements, including quality requirements, for manufacture of the Qwik-Let Lite Lancing Devices before (b)(4) began manufacturing this product line in August 2007. (We recognize that (b)(4)no longer manufactures this product line for you.)
We have reviewed your February 23, 2009, response to the Form FDA 483. You stated in this response that the firm intended to take a number of corrective and preventive actions, including: collect information for and create a complete DHF for the Stat Super-Fine Insulin Pen Needle by May 20, 2009; test and document compatibility of this device with different insulin pen injectors on the market by May 20, 2009; have an independent lab conduct and report on biocompatibility and toxicity tests for the (b)(4) Stat Super-Fine Insulin Pen Needle by May 30, 2009; generate and complete a revised risk analysis for the Stat Super-Fine Insulin Pen Needle by May 15, 2009; generate and properly release an EO Sterilization SOP by April 30, 2009; train personnel on this EO Sterilization SOP; develop a new procedure and evaluation checklist to evaluate new potential vendors by March 20, 2009; and train personnel on using this new procedure and checklist. This response is inadequate because you have failed to provide any supporting documentation to demonstrate that you have implemented the actions identified in your response. Your corrective actions will be reviewed at a follow-up inspection of your facility.
Our inspection also revealed that your devices are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under Section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 ~ Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to submit an report within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that the marketed device has malfunctioned and that such device or similar device marketed by the manufacturer would be likely to cause death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
• For example, your firm failed to report two failures of its Stat-Let Clinical Safety Lancets to retract during use, as referenced in Complaint 07-015 dated November 22, 2007. Although an employee of your firm determined that these events were not reportable under 21 CFR 803.50, we have evaluated these events and disagree with this assessment. We have determined that these failures to retract are a malfunction under 21 CFR 803.3 and that the device would be likely to cause or contribute to death or serious injury were this malfunction to recur. 21 CFR 803.50(a)(2).
We have reviewed your firm's February 23, 2009, response to the Form FDA 483. In this response you stated that your firm intended to: submit an MDR to the FDA on the above-referenced incident by February 24, 2009; review all complaints reported in the last three years to assess whether MDR filings are necessary and file any such MDRs by April 30, 2009; provide additional training to personnel on MDR filings; and revise complaint forms to include a list of questions to determine accurately the need for MDR filings. This response is inadequate because it lacks supporting documentation to demonstrate that you have implemented these corrective and preventive actions. Please submit supporting documentation, such as· training agendas, attendance logs, revised complaint forms, and evidence of MDR filings, to demonstrate implementation of these actions.
Our inspection also revealed that the Stat Super-Fine Insulin Pen Needle with (b)(4) is adulterated under Section 501(f)(1 )(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do 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 (IDE) 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), because you did not notify the agency of your 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) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
• A review of FDA's records revealed that the Stat Super-Fine Insulin Pen Needle ((b)(4) ) was cleared on April 22, 2005 for use with a pen injector device for the subcutaneous injection of insulin. Your Current device is not covered by this 510(k) clearance because it has been significantly changed through the addition of (b)(4) to the needle. This (b)(4) is a change or modification that could significantly affect safety and effectiveness of the device and therefore triggers the requirement for a new 510(k). 21 CFR 807.81(a)(3)(i). Your firm has not, however, submitted a new 510(k) for the Stat Super-Fine Insulin Pen Needle with (b)(4)
By letter to FDA dated December 3, 2008, your firm stated that it would "suspend any and all domestic sales of the Super-Fine Insulin Pen Needles [with (b)(4)] effective immediately" and lasting until a new 510(k) has been submitted and the device has been cleared by FDA. In your February 23, 2009, response, you stated that, "A special 510(k) with biocompatibility, toxicity and product labeling will be submitted to the FDA by June 15, 2009." We will evaluate your submission when we receive it.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to , seizure, injunction, and/or civil money penalties. Also, 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Alejo at (407) 475-4731.
You should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the lnspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of these violations, and take prompt actions to correct the violations and to bring your products into compliance.
Finally, although your firm has committed to suspending any and all domestic sales of the Stat Super-Fine Insulin Pen Needle with (b)(4), your firm has not addressed whether it will pursue a voluntary correction to or removal of any such products that are currently in distribution. As stated in previous paragraphs of this Warning Letter, the Stat Super-Fine Insulin Pen Needles with (b)(4) are considered to be adulterated under Sections 501(f)(1)(B) and 501(h) of the Act, 21 U.S.C. 351(f)(1)(B) and 351(h), and misbranded under Section 502(o) of the Act, 21 U.S.C 352(o). FDA has concerns regarding their safety and effectiveness. Should your firm undertake a voluntary correction or removal of the Stat Super-Fine Insulin Pen Needle with (b)(4), it must submit a written report to FDA within 10 days of initiating an action, as specified 21 CFR 806.10(a) & (b). See 21 CFR 806.10 for additional requirements governing reports of voluntary corrections and removals.
Director, Florida District