Inspections, Compliance, Enforcement, and Criminal Investigations
Northern Implants L.L.C. 09-Nov-04
Department of Health and Human Services
Public Health Service
Baltimore District Office
November 9, 2004
RETURN RECEIPT REOUESTED
Mr. Ernest A. Carroll, Managing Director
Northern Implants LLC.
10355B Democracy Lane
Fairfax, VA 22030
Dear Mr. Carroll:
During an inspection of your establishment located in Fairfax, Virginia on September 22 through October 4, 2004, our investigator determined that your establishment manufactures endosseous implants. See 21 CFR 820.3(o) (defining "manufacturer"). These products are devices as defined by Section 201(h) of the Federal Food Drug, and Cosmetic Act (the Act).
The above-stated inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. At the close of the inspection, you were issued a Form FDA-483 which delineated a number of CGMP inspectional observations, which 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 the specified design requirements are met [21 CFR 820.30]. Specifically,
a. Procedures for addressing incomplete, ambiguous, or conflicting design input requirements were not established as required by 21 CFR §820.30(c).
b. Procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements were not established as required by 21 CFR §820.30(d).
c. Procedures for planning and conducting reviews of the design results at appropriate stages of the design development of the device were not established as required by 21 CFR §820.30(e).
d. Procedures for verifying that design output meets design input were not established as required by 21 CFR §820.30(f).
e. Procedures for validating the device design were not established as required by 21 CFR §820.30(g).
f. Procedures were not established to ensure that the device design was correctly transferred into production as required by 21 CFR §820.30(h).
g. The design history file for the endosseous implant was not established as required by 21 CFR §820.30(j)
2. Management with executive responsibility failed to review the suitability and effectiveness of the quality system to ensure that the quality system satisfies the requirements in 21 CFR 820 and your quality policy as required by21 CFR 820.20(c).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA-483 issued at the conclusion of the inspection maybe symptomatic of serious underlying problems in your establishment's quality system. You are responsible for investigating and determining the cause of all inspectional observations listed in the Form FDA-483 issued to you. You also must promptly initiate permanent, corrective and preventive actions on your Quality System.
We acknowledge receipt of your letter dated October 6, 2004 in response to the FDA-483 issued to you at the conclusion of the above inspection. Our review of your response indicates it does not contain sufficient information to determine the adequacy of the proposed corrective actions. In the response, you state you take exception to FDA's application of the term "specification developer" to Northern Implants. A manufacturer is defined in 21 CFR 820.3(o) as "any person who designs, manufactures, fabricates, assembles, or processes a finished device." Based on information collected during the inspection, we determined Northern Implants falls within the definition of manufacturer in that your establishment designed the endosseous implant and provided this design to your contract manufacturer.
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, no pre-market submissions for Class III devices to which the Quality System/GMP deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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, civil penalties, and/or taking steps to refuse these devices, including placing them on detention without physical examination upon entry into the United States until the corrections are completed.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. Include all the documentation of the corrective actions you have taken. If the corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. To assist you in your corrective actions, several guidance documents are available on FDA's website at http://www.fda.gov/cdrh/comp/gmp.html. For your convenience and to assist you in your corrective actions, I have attached a copy of the federal register notice announcing the final rule for 21 CFR part 820 and two of the available guidance documents related to design controls.
Your response should be sent to Mr. Steven B. Barber, Compliance Officer, Food and Drug Administration, 6000 Metro Drive; Suite 101, Baltimore, MD 21215. If you have any questions, please contact Mr. Barber at (410) 779-5134.
Roberta F. Wagner
Acting District Director
Federal register dated. 10/7/1996
Design Control Guidance for Medical Device Manufacturers
HHS Publication FDA 97-4179 (introduction and Chapter 3 only)