Inspections, Compliance, Enforcement, and Criminal Investigations
The Lebanon Corp., Inc. 5/17/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
May 17, 2012
Mr. David A. Honan
The Lebanon Corp., Inc.
1700 North Lebanon Street
Lebanon, Indiana 46052-7273
Dear Mr. Honan:
During an inspection of your firm located in Lebanon, Indiana, from December 19, 2011, through February 24, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Honan Intraocular Pressure Reducer. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
This inspection revealed that this device is 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, its manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
The violations found during the inspection and subsequent review include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
a. Your firm’s procedure under the “820.100 Corrective and Preventive Action” tab of the quality manual states that, “(b)(4).” However, the procedure fails to indicate the means and frequency of analysis pertaining to quality data sources.
b. From January 1, 2007, to January 17, 2012, your firm made (b)(4), finished Honan Intraocular Pressure Reducer devices and documented 1045 receiving inspection failures, 661 in-process failures, and 12 final inspection failures. However, quality data sources (service records; complaints; and receiving, in-process, and final-inspection records) were not analyzed to identify existing and potential causes of non-conforming product.
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
a. Your firm’s current procedures under the “820.198 Complaint Files” tab in the quality manual states that (b)(4) However, the procedure failed to:
1) Define a complaint in order to allow the firm’s personnel to appropriately identify complaints.
2) Indicate what information must be documented to ensure that all complaints are handled in a uniform and timely manner.
3) Clearly define complaint follow-up activities to indicate how the complainant will be contacted to determine the circumstances of the complaint event.
4) Define complaint evaluation criteria for determining if a complaint meets the definition of a reportable event and if an investigation is necessary.
b. Your firm stated that from January 1, 2007, thru January 17, 2012, it never received any complaints regarding its device. However, review of your firm’s top (b)(4), customers revealed that there were 32 service reports that had not been investigated or reviewed.
3. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm’s procedure under tab “820.90 Nonconforming Product” in the quality manual, Page 2, does not address the evaluation of non‑conforming products to determine if there is a need for an investigation into quality problems. Additionally, from January 1, 2007, to January 17, 2012, there have been 661 in-process failures resulting in non-conforming products. However, your firm failed to evaluate these failures to determine the need for an investigation.
4. Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, your firm’s design control procedures under the “820.30 Design Controls” tab in the quality manual state “(b)(4)” Your firm, however, made several design changes to the device, including: a design change on March 31, 1999, for the (b)(4) a design change on October 22, 2007, for the (b)(4) and a design change on April 29, 2011, for the addition of a (b)(4). These changes were not made according to an established procedure that addresses the identification, documentation, validation or, where appropriate, verification, review, and approval of the design change prior to implementation.
5. Failure to establish and maintain adequate data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 CFR 820.50(b). For example, your firm’s purchasing control procedure under tab “820 Purchasing Controls” in the quality manual states that “(b)(4) However, the DMR that corresponds to the bellows and air inlet discs does not have specific dimensions or tolerances for the molds that are used by the supplier to produce components.
6. Failure to maintain adequate procedures to control all documents, as required by 21 CFR 820.40. For example, your firm’s procedure under the “820.40 Document Controls” tab in the quality manual, page 2, (b)(4) In addition, the procedure states that modified documents will (b)(4) However, your firm’s Relief Valve Assembly procedure was located in multiple sections of the quality manual and the procedure is not labeled to indicate effective date, change authorization date, and authorization signature.
7. Failure to analyze service reports with appropriate statistical methodology, as required by 21 CFR 820.200(b). For example, your firm’s procedure under the “820.200 Servicing” tab of the quality manual states that the device has (b)(4) However, your firm’s procedure lacks the requirement to analyze service reports with appropriate statistical methodology in accordance with 21 CFR 820.100. Additionally, your firm has not performed data analysis on any service reports since 2007.
8. Failure to maintain an adequate device master record DMR, as required by 21 CFR 820.181. For example, your firm’s DMR, located under tab “820.181 Device Master Record” in the quality manual contains drawings of components and exploded views of the Honan Intraocular Pressure Reducer device assembly. However, the DMR does not contain the dimensional specification and tolerances for the bellows, bases, and relief valve assembly component.
9. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of part 820 and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented, as required by 21 CFR 820.20(c). For example, during the inspection, your firm stated that it has not defined, documented, and implemented the procedure to specify the means and frequency by which the quality system is evaluated. Additionally, your firm stated that the quality system has never been reviewed for suitability or effectiveness.
10. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm has not documented any training to indicate that employees are familiar with procedures specific to your firm’s quality manual and to activities specific to each employee’s role.
Additionally, our inspection revealed that your firm’s Honan Intraocular Pressure Reducer is 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). Significant violations include, but are not limited to, failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. Your firm does not have any MDR reporting procedures and acknowledges that it is unaware of the requirements of 21 CFR 803 and lacks MDR procedures.
The FDA granted your company marketing clearance for the Honan Intraocular Pressure Reducer, K820526, on March 25, 1982. Our recent review of your firm’s website, www.honanballoon.com, demonstrates that your firm is making claims that represent a major modification of the intended use of the device. Objectionable claims include, “Application after injection anesthesia . . . can enhance the effect of anesthesia.” This claim has not been cleared by the FDA.
Additionally, your firm’s website, www.honanballoon.com demonstrates that your firm is selling the Honan Intraocular Pressure Reducer without the relief valve. However, the device has not been cleared to be used without a relief valve.
Finally, the Honan Intraocular Pressure Reducer instructions for use state, “Preparation For Use…Sterilize the Head-band, Bellows and Tubing (parts that touch the face), using your choice of the following methods: 1. Cleanse with a recognized sterilizing solution. Wipe Clean, Do not immerse. 2. Sterilize in Auto-Clave. Note: Only units received after Sept. 15, 1979 can be Auto-Claved. 3. Sterilize by the Gas Method. For those who prefer to use this more time consuming method, pack in sets of three each are available. These plus the one supplied with the Reducer provide for surgery on four patients between sterilization.” However, the device, as referred to in the language of the 510(k), K820526, is a single-use device that was not meant to be used without first being sterilized.
The noted claims, instructions for use, and manner of sale go beyond the marketing clearance for this device. Therefore the Honan Intraocular Pressure Reducer 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 Honan Intraocular Pressure Reducer is also misbranded under Section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its 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) 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. 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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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.
Please notify this office in writing within fifteen business 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 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: CDR Kimberly Y. Martin, Compliance Officer, Detroit District Office, Food and Drug Administration, HFR-CE7560, 101 W. Ohio Street, Suite 500, Indianapolis, Indiana 46204. If you have any questions about the contents of this letter, please contact CDR Martin at 317-226-6500 ext. 116.
Finally, 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 the 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 devices into compliance.
Glenn T. Bass
Detroit District Office