Inspections, Compliance, Enforcement, and Criminal Investigations
Health Science Products Inc 1/12/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Orleans District|
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
January 12, 2012
WARNING LETTER NO. 2012-NOL-11
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Michael A. Muscari
Senior Vice President and Co-Owner
Health Science Products, Incorporated
1489 Hueytown Road
Hueytown, Alabama 35023-2061
Dear Mr. Muscari:
During an inspection of your firm located in Hueytown, Alabama, on July 20, 2011, and August 10, 2011, an investigator from the United States Food and Drug Administration (FDA) determined your firm manufactures dental chairs and dental operative units. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) § 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 these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC§ 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. Noted violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm does not have a written CAPA procedure.
2. Failure to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm does not have written procedures for purchasing controls.
3. 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). For example, your firm does not have a written complaint procedure.
4. Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 CFR 820.70(a). For example, your firm does not have written process control procedures or work instructions for its dental operative units.
5. Failure to adequately document acceptance activities, as required by 21 CFR 820.80(e). For example, your firm does not document all acceptance activities.
6. Failure to maintain adequate device master records (DMRs), as required by 21 CFR 820.181. For example, your firm failed to maintain DMRs for its dental operative units which includes or refers to the location of all devices, production process, quality assurance, and packaging and labeling specifications. In addition, installation, maintenance, and servicing procedures and methods are not adequately maintained.
7. Failure to maintain adequate device history records (DHRs), as required by 21 CFR 820.184. For example, your firm failed to maintain an adequate DHRs which includes or refers to the location of all acceptance records, primary identification label or labeling, and any device identification and control numbers used for its dental chairs and dental operative units.
8. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm does not have written procedures for document controls.
Our inspection also revealed your firm's devices are misbranded under Section 502(t)(2) of the Act, [21 USC§ 352(t)(2)], because your firm failed or refused to furnish material or information respecting the device which is required by or under Section 519 of the Act, [21 USC§ 360i], and 21 CFR 803- Medical Device Reporting (MDR). Significant violations include, but are not limited to, the following: failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
We received your response dated August 25, 2011, concerning our investigator's observations noted on the FORM FDA 483, List of Inspectional Observations, which was issued to your firm. The response is inadequate because it did not include any specific actions you have taken, or plan to take, to correct the violations.
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 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 (15) 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 recurring. You should include documentation of the corrections and/or corrective actions (including any systemic corrective actions) 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.
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 FORM 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.
Your firm's response should be sent to Kari L. Batey, Compliance Officer, at the address above. If you have any questions about the contents of this letter, please contact: Kari L. Batey at (615) 366-7808.
Patricia K. Schafer
New Orleans District