Inspections, Compliance, Enforcement, and Criminal Investigations
Bennett Industries, Incorporated 16-Sep-05
Department of Health and Human Services
|Public Health Service |
Food and Drug Administration
|New Orleans District|
297 Plus Park Blvd
Nashville, TN 37217
September 16, 2005
WARNING LETTER NO. 2005-NOL-33
George Hubert Bennett, Jr., President/CEO
Bennett Industries, Incorporated
1805 Burgess Falls Road
Cookeville, TN 38506
Dear Mr. Bennett:
On May 18 and 23, 2005, the United States Food and Drug Administration (FDA) conducted an inspection of your firm, located x: 1805 Burgess Falls Road, Cookeville. Tennessee. FDA has determined your firm manufactures pediatric cribs and crib tops. These products are manufactured pursuant to a contract with [redacted] located at [redacted], and are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and associated regulations through links at FDA's Internet home page at http://www.fda.gov.
The above-stated inspection revealed the devices are adulterated under Section 501(h) of the Act, as the methods used in, or the facilities or controls used for design, manufacturing, packing, labeling, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR). Part 820. Significant deviations found during the inspection include, but are not limited to, the following:
1. Your firm has not established an effective management control system, as required by 21 CFR 820.20. Specifically:
Management with executive responsibility has not been appointed to ensure the quality policy is understood implemented and maintained at all levels of your organization [21 CFR 820.20(a)].
Management review have not been documented, as required by 21 CFR 820.20(c).
A quality plan has not been established which defines the quality practices, resources and activities relevant to devices designed and manufactured by your firm [21 CFR. 820.20(d)]
2. Your firm has not established and implemented procedures for the following:
Receiving reviewing and evaluating, complaints in a uniform and timely manner, as required by 21 CFR 820.198. You have no procedure for investigating or evaluating complaints to determine if a Medical Device Report (MDR) should be filed [21 CFR 803.
Design changes before implementation as required by 21 CFR 820.30(i). Specifically, you changed the design of the side rail by adjusting the size of the railing and spacers on all beds manufactured at your facility. Your firm did not document review, or approve this change prior to the implementation;
Production and process controls to ensure conformance to specifications, as required by 21 CFR 820.70(a). Specifically, during our inspection, you stated the cribs have been manufactured for over 35 years and employees knew the specifications "in their heads". Your firm does not have written procedures describing any process controls used to ensure conformance to device master record (DMR) specifications;
Acceptance activities for receiving, in process, and finished device testing, as required by 21 CFR 820.80(a). Specifically, during our inspection, you indicated the defective raw materials would be rejected and returned to the supplier. Your firm does not have written procedures covering the device acceptance process;
Control of labeling activities, such as label examination, acceptance of new labels, handling instructions, storage, and release of labels for use in production, as required by 21 CFR 820.120;
Routine inspection and maintenance of equipment. Your firm does not document equipment maintenance activities, as required by 21 CFR 820.72(a). In addition, your firm lacks schedules for the adjustment, cleaning, and other maintenance of equipment, as required by 21 CFR 820.70(g)(1);
Identification of employee training needs, as required by 21 CFR 820.25(b);
Implementation and frequency of quality audits, as required by 21 CFR 820.22; and,
Implementation of corrective and preventive actions (CAPA), as required by 21 CFR 820.100(a). Your firm has not documented all activities, as required by 21 CFR 820.100(b). Specifically, your firm failed to document the corrective and preventive actions taken resuIting from the receipt of complaint numbers 160 and 166 involving pediatric cribs and crib tops.
3. Your firm does not include or refer to the location in the DMR of all specifications [21 CFR 820.181(a)], and location of packaging and labeling procedures and specifications [21 CFR 820.181(d)]. Specifically, a parts list provided to investigators during our inspection was identified by our firm as a DMR. This information did not include the location of device specifications, packing and labeling procedures or specifications.
4. Your firm does not maintain adequate and complete device history records (DHR) as required by CFR 820.184. Specifically, an inventory/shipping list provided to investigators during our inspection was identified as the DHR. This record lacked acceptance records to demonstrate the device was manufactured according to the the specification and procedures in the device master file and labeling for each production unit.
5. Your firm's DHR does not include complete records of approval and release of device labeling, including date and signature of the examiner, as required 21 CFR 820.120(b). Specifically, there is no documentation of approval and release of device labeling included in the DHR, nor is there a signature and date of the person performing the review.
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 close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.
Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts . Additionally, no premarket submission for Class III devices to which the Quality System/GMP 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 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Please notify this office in writing within fifteen (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 prevent the recurrence of similar violations. If corrective action cannot be completed within 1 5 working days, state the reasons for the delay and the time within which the correction will be completed.
Your reply should be directed to Kimberly L. McMillan, Compliance Officer, U.S. Food and Drug Administration, 297 Plus Park Boulevard, Nashville, Tennessee 37217. If you have questions concerning the violations noted, please contact Ms. McMillan at (.615) 781-5380, extension 138.
Howard E . Lewis, Jr.
ActinE, District Director
New Orleans District