Inspections, Compliance, Enforcement, and Criminal Investigations
Intec Industries Inc
Department 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) 366·7801
FAX: (615) 366·1802
September 3, 2010
WARNING LETTER NO. 2010·NOL·19
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Frank: L. Lee, President
Intec Industries, Inc.
2024 12th Avenue North
Birmingham, Alabama 35234
Dear Mr. Lee:
On August 3, 4 and 10, 2010, an investigator from the United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 202412 Avenue North, Birmingham, Alabama. This inspection determined you manufacture face shields and extended eye shields with masks, 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)] 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 Title 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 August 10, 2010, a Form FDA 483, Inspectional Observations, was issued to you. A copy 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 develop Medical Device Reporting procedures (21 CFR 803.17).
2. 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.
3. 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.
4. 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.
5. Failure to establish written procedures for management review [21 CFR 820.20(c)]. There are no procedures to assess the suitability and effectiveness of the quality system at defined intervals.
6. Failure to establish procedures for quality audits (21 CPR 820.22). There is no assurance the quality system is in compliance.
7. Failure to establish written procedures for training and identifying training needs [21 CFR 820.25(b)]. Employees have not been trained to recognize device defects and records are deficient to cover all training received.
8. Failure to establish written procedures to control product which does not conform to specified requirements [21 CFR 820.90(a)]. There are no procedures for handling and controlling non-conforming products.
9. Failure to maintain device master records with all of the required information (21 CFR 820.181). For example, the records do not include production process specifications, quality assurance procedures and acceptance criteria specifications, and packaging and labeling specifications.
10. Failure to establish written procedures to cover device history records (21 CFR 820.184). There is no assurance the device is manufactured in accordance with the device master record, and the device history record is not documented during the actual manufacturing process. No labeling is included in the record.
11. Failure to document in-process inspections, tests, or other verification activities and approvals [21 CFR 820.80(c)]. The Quality Assurance Program was not followed when required to document in-process acceptance activities performed during production, and there was no documentation of the acceptance activities or rejected incoming materials as required by written procedures.
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.
FDA received your written response dated August 18, 2010, to the Form FDA 483, Inspectional Observations, and this information has been made a part of our official files. Your response is inadequate because it does not provide any information or documents to reflect you have made any corrections to the listed observations.
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 Karl L. Batey, Compliance Officer, U.S. 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.
H. Tyler Thornburg
New Orleans District