Inspections, Compliance, Enforcement, and Criminal Investigations
Multi-Med, Inc. 10/7/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District|
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
VIA CERTIFIED MAIL
October 7, 2009
Mr. Alan P. Reid, President
2 Winchester St/P.O. Box 660
West Swanzey, NH 03469
During an inspection of your firm located in West Swanzey, NH conducted September 1st through September 11th, 2009 an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures infant feeding tubes. 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 Practices (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
Significant violations include, but are not limited to, the following:
Failure to establish1and maintain written procedures to control the design of devices, as required by 21 CFR 820.30. For example,
A. Design validation was not executed or documented in order to ensure that the devices conform to defined user needs and intended uses. The design validation must include testing of production units under actual or simulated use conditions, and risk analysis, where appropriate as required by 21 C.F.R. § 820.30(g). Design validation has not been completed for the NeoDevices Silicone Enteral Feeding Tube or the NeoDevices Polyurethane Enteral Feeding Tube.
B. A design and development plan, for the NeoDevices Silicone Enteral Feeding Tube, that describes or references the design and development activities and define responsibility for implementation was not established or maintained by your firm as required by 21 CFR 820.30(b).
C. A design history file was not established or maintained by your firm, as required by 21 C.F.R. § 820.30(j). Your firm also has no records identifying design inputs, design outputs, design review, or design verification for the NeoDevices Silicone Enteral Feeding Tube as required by 21 C.F.R. §§ 820.30(c)-(f).
The Agency acknowledges the two written submissions made by your firm to address the deficiencies cited on the FDA 483. We acknowledge your commitment to execute design validation and to establish design history files which include documentation of design inputs, outputs, verification and validation testing, and risk analysis. The Agency is unable to evaluate the promised actions at this time because the submissions lacked sufficient detail and supporting documentation.
You should take prompt action to correct the violations addressed above 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.
Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations 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.
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 Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s quality assurance systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations and to bring your products into compliance.
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. You should include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of these 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:
Amber Wardwell, Compliance Officer
U.S. Food & Drug Administration
New England District Office
One Montvale Ave.
Stoneham, MA 02180
If you have any questions about the content of this letter please contact Ms. Wardwell at (781) 596-7823.
John R. Marzilli
U.S. Food & Drug Administration
New England District
1 The terms “establish” or “established,” as used in this letter, follow the definition at 21 C.F.R. § 820.3(k), and mean “define, document (in writing or electronically), and implement.”