Inspections, Compliance, Enforcement, and Criminal Investigations
H & H Associates 4/30/12
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
April 30, 2012
Mr. Robert H. Harder
H & H Associates
4173 G. W. Memorial Highway
Ordinary, Virginia 23131
Dear Mr. Harder:
During an inspection of your firm located in Ordinary, Virginia, on December 1, 2011, through January 10, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the H & H Emergency Cricothyrotomy Kit and Chest Tube Insertion Kit. 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 to affect the structure or any function of the body.
The H & H Emergency Cricothyrotomy Kit 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), 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. Specifically, the H & H Emergency Cricothyrotomy Kit requires 510(k) clearance as it is labeled as a "sterile, single use kit for the performance of an emergency cricothyrotomy." Documentation of performance validation, biocompatibility, clinical validation, and usability would be reviewed under the 510(k) clearance review paradigm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
This inspection also 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. FDA received a response from you dated January 31, 2012, concerning the investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, that was issued to your firm. FDA addresses this response below. Your firm's responses to the FDA 483 dated February 3, 2012, and February 28, 2012, were not reviewed because they were not received within fifteen business days of issuance of the FDA 483. These responses may be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Your firm does not have documented procedures to control the design of its devices, specifically with respect to design input, design output, design review, design verification, design validation, design change, and design transfer. Your firm failed to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. Additionally, your firm failed to establish and maintain a Design History File for each type of device.
2. Failure to adequately ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). Specifically, your firm does not have a documented procedure for validation of the hermetic healing process for its kits, with a high degree of assurance.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm does not have a documented procedure for corrective and preventive action.
4. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). Specifically, your firm does not have a documented procedure for finished device acceptance.
5. Failure to establish and maintain procedures for developing, conducting, controlling, and monitoring production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). Specifically, your firm does not have a documented process control procedure that describe any process controls necessary to ensure conformance to specifications.
6. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm does not have a documented procedure for handling complaints.
7. Failure to establish and maintain procedures to control all documents that are required by 21 CFR Part 820, as required by 21 CFR 820.40. Specifically, your firm does not have a documented procedure for the control of documents.
8. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Specifically, your firm failed to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system.
9. Failure to establish and maintain management responsibility, as required by 21 CFR 820.20. Specifically, your firm failed to have management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, according to established procedures, (1) to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer's established quality policy and objectives; (2) to establish procedures for management reviews; and (3) to establish a quality policy and quality objectives.
Your firm's response, dated January 31, 2012, is not adequate. Your firm's response states that the implementation of all recommended changes to its activities in light of the gap analysis recommendations and the inspectional findings has commenced. A chart of procedures to be developed for the planned quality system was also provided in your response. But your firm did not provide evidence of documentation and implementation of the developed procedures.
FDA's inspection also revealed that your firm's 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. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Specifically, your firm does not have a documented procedure for Medical Device Reporting.
FDA reviewed your firm's response and concluded that it is not adequate. Specifically, your firm did not provide evidence of documentation and implementation of a Medical Device Reporting procedure.
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. 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 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: U.S. Food and Drug Administration, Attention: Evelyn Bonnin, District Director, at 6000 Metro Drive, Suite 101, Baltimore, MD 21215. When replying, refer to the Unique Identification Number CMS case# 284038. If your firm has any questions about the contents of this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer at 410-779-5437 via telephone or 410-779-5705 via fax.
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 Office