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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Eaton Manufacturing Corporation Dba Eaton Medical

 

Department of Health and Human Services logoDepartment 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: 615-781-5385
FAX: 615-781-5391

July 27, 2010

WARNING LETTER NO. 2010-NOL-17

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

Bron Eaton, President
Eaton Manufacturing Corporation
dba Eaton Medical
1401 Heistan Place
Memphis, Tennessee 38104-4729

Dear Mr. Eaton:

On June 23 & 25, 2010, an investigator from the United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1401 Heistan Place, Memphis, Tennessee. This inspection determined you manufacture post mydriatic protective eyewear and contact lens cases, which are medical devices as described under Section 201 (h)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 321(h)(2)] because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.

The devices you manufacture are adulterated under 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 are not in conformity with 21 Code of Federal Regulations, Part 820 (21 CFR 820), Quality System (QS) regulations. The Act and related device regulations can be found through links at our Internet homepage at www.fda.gov.

On June 25, 2010, a Form FDA 483, Inspectional Observations, was issued to (b)(6) Warehouse Manager. A photocopy of this document is enclosed for your reference. The serious deviations noted during the inspection include, but are not limited to, the following:

1. Failure to establish QS procedures and instructions [21 CFR 820.20(e)]. There are no written quality system procedures and instructions for the manufacture and distribution of your contact lens case device.

2. Failure to develop and implement Medical Device Reporting procedures (21 CFR 803.17).

3. Failure to establish written procedures for Corrective and Preventive Action [21 CFR 820.100(a)]. There are no measures in place to investigate a device non-conformance and determine the disposition and preventive course for recurrence of the device failure.

4. Failure to establish and implement written procedures for acceptance of incoming products [21 CFR 820.80(b)]. There is no assurance of the identity and quality of the incoming devices since there are no tests or verification steps to assure the devices meet established specification requirements.

5. Failure to establish written procedures for receiving, reviewing, and evaluating complaints by a formally designated unit [21 CFR 820.198(a)]. There is no complaint handling system to investigate complaints and determine the disposition of the issue at hand.

6. Failure to establish written procedures to ensure all purchased or otherwise received product and services conform to specified requirements (21 CFR 820.50). There are no specifications for purchasing controls.

7. Failure to establish device history records (21 CFR 820.184). There is no documentation of the manufacture of each device.

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations which exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure your firm complies with all requirements of Federal law and FDA regulations. Other agencies may take this warning letter into account when considering the award of contracts. Recurrence of the aforementioned deviations may result in legal action without further notice, including, without limitation, seizure and injunction.

You are requested to 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 prevent the recurrence of violations or similar violations. Please explain and include documentation of any corrective action you have taken. If these corrective actions will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.

Please send your reply to Kari L. Batey, Compliance Officer, Food and Drug Administration, at the above address. Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.

Sincerely,
/S/
H. Tyler Thornburg
District Director
New Orleans District

cc: (b)(6), Warehouse Manager
Eaton Manufacturing Corporation
dba Eaton Medical
1401 Heistan Place
Memphis, TN 38104-4729