Inspections, Compliance, Enforcement, and Criminal Investigations
EM Innovations, Inc 01-Apr-06
Department of Health and Human Services
Public Health Service
Cincinnati District Office
March 31, 2006
VIA FEDERAL EXPRESS
Ms. Connie S . Lewis, President
EM Innovations, Inc.
6106 Bausch Road
Galloway, OH 43119-9382
Dear Ms. Lewis:
During an inspection of your establishment located in Galloway, Ohio, completed on February 10, 2006, our investigators determined that your firm is a specification developer for medical sharps containers that are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 321(h)].
The above-stated inspection revealed devices produced according to specifications developed by your firm 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 manufacturing, packing, storage, or installation are not in conformance with the Quality System (QS) regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820.
At the close of the above-stated inspection, your firm was issued a List of Inspectional Observations, Form FDA-483, which identified a number of QS regulation violations, including, but are not limited to, the following:
1. Your firm has not established procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Moreover, you changed the design for the Stic Kit needle containment device twice without following any design change control procedures. [FDA-483, Item 2]
2. Your firm has not implemented a corrective and preventive action procedure for the Stic Kit needle containment device that includes the following: a) the identification of existing and potential causes of nonconforming product ; b) the investigation of the cause of nonconformities; c) verifying or validating the effectiveness of corrective and preventive action; d) identifying the action needed to correct and prevent problems; and e) implementing changes needed to correct and prevent problems; as required by 21 CFR 820.100(a). [FDA-483, Item 1]
3. Your firm's records provided as the device master record were incomplete and did not contain or refer to the location of information such as packaging and labeling specifications, device specifications to include the mold currently in use, and quality assurance procedures which address nonconforming product, as required by 21 CFR 820.181. [FDA-483, Item 4]
4. Your firm has not established labeling procedures to include inserting the Stic Kit User Instructions into the device packaging before shipment to customers, as required by 21 CFR 820.120. [FDA-483, Item 6]
5. Your firm has not defined and documented procedures for addressing the identification, documentation, evaluation, segregation, disposition, and investigation of nonconforming product, as required by 21 CFR 820.90(a). For example, your firm does not have defined and documented procedures addressing the 100% review performed during final packaging, and evaluation of returned Stic Kit needle containment devices. In addition, your firm does not document any nonconforming products received from the manufacturer . [FDA-483, Item 7]
6. Your firm does not have procedures which describe how the documents your firm is required to keep as part of the Quality System Regulation will be controlled and managed for the Stic Kit needle containment device, as required by 21 CFR 820.40. [FDA-483, Item 3]
7. Your firm has not established procedures, and there is no evidence that management with executive responsibility has performed a review, to ensure the quality system satisfies your firm's quality policy and objectives for the Stic Kit needle containment device, as required by 21 CFR 820.20(c). [FDA-483, Item 5]
8. Your firm does not have procedures for conducting quality audits, and there is no evidence that quality audits have been conducted to verify that the quality system is effective in fulfilling the quality system objectives, as required by 21 CFR 820.22. [FDA-483, Item 8]
This letter is not intended to be an all-inclusive list of violations 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 may be symptomatic of serious problems in your firm's quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA.
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 premarket submissions for Class III devices to which the QS regulation 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 granted until the violations related to the subject devices have been
You should continue to take prompt action to correct any and all 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, and/or civil money penalties.
We have received your letter dated March 11, 2006 responding to the FDA-483 that was issued at the conclusion of the inspection. The effectiveness of your corrective actions will need to be verified at a later inspection of your firm. Please notify this office within fifteen (15) working days of the receipt of this letter of any additional corrective actions you have taken or will take to identify and correct the noted violations, including (1) timeframes within which the corrections will be completed, (2) any documentation that indicates that corrections have been achieved, and (3) 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.
Your response should be sent to Mr. Stephen J. Rabe, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Mr. Rabe at (513) 679-2700, ext. 163, or you may forward a facsimile to him at (513) 679-2773.
Carol A. Heppe