| Public Health Service Food and Drug Administration |
Cincinnati District Office |
Department of Health and Human Services
July 20, 2011
WARNING LETTER
CIN-11-187772-25
Via United Parcel Service
Mr. William N. Hardin
President and Quality Assurance Manager
Electro-Cap International, Inc.
1011 West Lexington Road
Eaton, Ohio 45320
Dear Mr. Hardin:
During an inspection of your firm located in Eaton, OH, on April 18, 2011, through April 28, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Electro-Cap and Electro-Gel products. 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 practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from you, dated May 18, 2011, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes before their implementation, per 21 CFR 820.30(i). For example, your firm indicated that it did not perform design change activities. Specifically:
A. Your firm stated to our investigator on 04/19/2011, that the Electro-Gel has undergone two product changes:
i. Testing in regards to conductivity, viscosity, biocompatibility, etc. was not performed when your firm switched from (b)(4) to (b)(4) and (b)(4). Your firm stated that it had literature research performed to support this change. This research was not documented and evidence of validation, or where appropriate verification, of the change was not provided upon request by the investigator.
ii. Approximately three years ago, your firm began using (b)(4), a combination of (b)(4), as a replacement for (b)(4). When asked about testing, your firm stated that the gel with the (b)(4) was sent to customers to use. The customers gave feedback in the form of e-mails. Testing in regards to conductivity, viscosity, biocompatibility, etc. was not performed on this change; evidence of validation, or where appropriate verification, of the change was not provided upon request by the investigator.
We have reviewed your firm's response and concluded that it is not adequate. Your firm stated that it approved the changes to the Electro-Gel. However, the change documents provided do not include any evaluation (including any test data) to assess the impact of these changes on the device. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
B. Your firm stated that occasionally it will change the viscosity of the gel by thickening it for customers who request the gel to be thicker. The investigator observed a jar with a hand-written procedure for making the gel more viscous when requested by a customer. In addition, your firm has not developed specifications for the viscosity.
We have reviewed your firm's response and concluded that it is not adequate. Your firm stated that it has purchased a new viscosity meter for viscosity testing, but did not provide the testing procedures for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
C. Your firm has performed three component changes to the design of the Electro-Cap without validating these changes. The silver/silver/chloride electrodes, the connectors, and the wire ties are all being purchased from different manufacturers. There was no testing or validation done regarding the changes made to these components.
We have reviewed your firm's response and concluded that it is not adequate. Your firm stated that the wire ties and connectors were changed through your Engineering Change Request system. Your change requests for the wire ties and connectors do not appear to contain a risk assessment or evaluation of the impact of the change to the finished device. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
2. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, per 21 CFR 820.80(d). For example:
A. Your firm has not been testing the conductivity of Electro-Gel since March 2011. Your firm indicated that Electro-Gel is used for conduction between the electrode and the skin. Upon request for the finished product testing in regards to this conductivity, your firm indicated testing for conductivity was not performed. On 04/20/2011, there was no procedure available regarding conductivity testing.
B. Your firm has no acceptance criteria for the viscosity of the gel. The "Manufacturing Procedure Gel" contains a Viscosity Check and a Quality Assurance Procedure. The Viscosity Check has a Method A and a Method B. Method A involves using a funnel and graduated cylinder to check the viscosity. Method B involves using a (b)(4). Both methods are not required to be performed by procedure on each lot of Electro-Gel. Your firm stated that there are currently no specifications for viscosity.
We have reviewed your firm's response and concluded that it is not adequate. Your firm stated that it has purchased a new viscosity meter and conductivity meter as part of your revision of current testing procedures for the Electro-Gel. No procedures for viscosity or conductivity testing were submitted for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
Our inspection also revealed that the Electro-Gel 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 (IDE) 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) of the Act is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]
The types of information that your firm must submit in order to obtain approval or clearance of your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. We will evaluate the information your firm submits and decide whether the product may be legally marketed.
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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and 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 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 that 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 reoccurring. Include documentation of the corrections and corrective actions that your firm has taken. If corrections and 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 Mark E. Parmon, Compliance Officer, Cincinnati District Office, 6751 Steger Drive, Cincinnati, OR 45237. Refer to the Unique Identification Number (CIN-11-187772-25) when replying. If you have any questions about the content of this letter, please contact Mr. Parmon at (513) 679-2700 ext. 2162.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your 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 to bring the products into compliance.
Sincerely yours,
/S/
Virginia R. Connelly
Acting District Director
Cincinnati District
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