- Battle Creek Equipment Co.
- Issuing Office:
- Detroit District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, Ml 48207
April 3, 2015
Battle Creek Equipment Co.
702 S. Reed Road
Fremont, IN 46767
Dear Mr. Underhill:
During an inspection of your firm located in Fremont, Indiana on January 27, 2015 through February 12, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufacturers the Thermo MaxHeat products, Custom Touch heating pads, and the Thermophore Classic heating pads. 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 to affect the structure or any 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 method, 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 Mr. Randy Newsome, Vice President and General Manager, dated February 23, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. We address this response below, in relation to 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, as required by 21 CFR 820.30(i). Your firm does not have a written design change procedure. Your firm did not validate or document justification for why verification of design change is appropriate in lieu of design validation. For example, your firm has made the following design changes to the Thermo MaxHeat, and the Thermo Classic heating pads:
a. Thermo MaxHeat products had a design change as documented by ECN #14-0026 dated March 10, 2014. The design change was from using an on/off switch to a high/medium/low switch. There was no validation or, where appropriate verification of this design change; and
b. The Thermophore Classic heating pads had a change from using a SPT wire cord to using a higher durability SVT wire cord as documented by ECN #13-0187, dated November 18, 2013. There was documentation that the supplier had performed testing, but you were unable to provide a testing protocol or testing raw data documenting the testing performed.
The adequacy of your firm’s response cannot be determined at this time. You have indicated the design process control procedure will be created. This is a planned action that we cannot evaluate at this time.
2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
a. Your Corrective and Preventive Action procedure does not define the identified actions needed to correct and prevent the recurrence of nonconforming products, including product in the market place. Corrective actions were implemented under PIPE #13-002 (Process Improvement/Product Enhancement Process) to apply new warning labels on existing SPT wire cord of the Thermophore Classic ( Models 055, 056, 077, 095, 096, 097) heating pad products; and your firm also implemented a design change in March 2014 by replacing the SPT wire cord with the SVT wire cord. However, your firm continues to receive complaints on the old SPT wire cord products still in distribution. Complaints #1851 and #2097 are for cord cut/burned at strain relief.
b. The Corrective & Preventive Action procedure states “Corrective and preventive actions can be initiated by any employee, as applicable through the use of Battle Creek Equipment Process Improvement/Product Enhancement Form (PIPE) System and Supplier Corrective Action Request form (SCAR)”. As a result of complaints, your firm implemented a design change and went from using on/off switch to high, medium, low and off switch for all MaxHeat products as per the ECN# 14-0026 dated March 10, 2014. However, neither a PIPE nor a SCAR was initiated as per your procedures.
The adequacy of your firm’s response cannot be determined at this time. You have indicated you will be making revisions to the CAPA procedure. These are planned actions that we cannot evaluate at this time.
3. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). Specifically, your Returned Product procedure, dated January 14, 2013; and S10027-Customer Feedback Work Instruction, dated May 16, 2013, do not include the following requirements:
a. An evaluation of complaints to determine whether an investigation is necessary and if an investigation is not necessary, the requirement to document the reason and the name of the person making the decision; and
b. Investigation of complaints regarding failure of device to meet device, labeling, or packaging specifications unless investigated previously.
Your firm does not investigate complaints if product is not returned. Six complaints, that were reportable events, found when you did not receive product back; you did not investigate the complaint.
The adequacy of your firm’s response cannot be determined at this time. You have indicated you are in the process of updating the QMS 6.0 Returned Product procedure. This is a planned action that we cannot evaluate at this time.
4. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, your Control of Nonconforming Product procedure states “(b)(4)”. However, a Nonconforming Material/Scrap Ticket was not generated when incoming samples did not meet specifications; and was not reviewed and evaluated to determine the need for investigation. For example:
a. For 5 of 12 DHRs reviewed for Thermophore MaxHeat Model 155, documentation on form S08286, “Inspection Form” for switches (Part #3054) (dated 1/28/2015, 12/11/2014, 1/3/2014, 2/14/2014) found samples did not meet the critical dimension specification; and
b. The DHR dated November 21, 2014 for Thermophore MaxHeat Model 155, found the amperage ranging from (b)(4) to (b)(4) for testing of final assembly for 211 heating pads produced that day. This was higher than the (b)(4) listed as “MAX AMPS” on S10474 “Testing Amperage Chart”, dated August 13, 2014.
The adequacy of your firm’s response cannot be determined at this time. You have indicated that you will create template and guidelines for creating work instructions. This is a planned action that we cannot evaluate at this time.
5. Failure to establish procedures for validating a process whose results cannot be fully verified as required by 21 CFR 820.75(a). Specifically, the S10417-Process Validation Work Instruction, dated March 27, 2014, documents the methodology for performing process validation. The validation protocol and the raw data for the validation process was not available to support the validation summary of “S10170 RF Welder Setting Validation Test” for machine (b)(4) and (b)(4) used for the welding of the thermostat seal.
The adequacy of your firm’s response cannot be determined at this time. You have indicated you will add documentation forms to the process validation work instructions and train the involved personnel. This is a planned action that we cannot evaluate at this time.
6. Failure to establish and maintain procedures for finished device acceptance, to ensure that each production run, lot or batch of finished devices meet acceptance criteria, as required by 21 CFR 820.80(d). Specifically, you do not have a procedure for finished device acceptance to ensure each production run of finished devices meets acceptance criteria. For example, the DHR dated November 21, 2014 for Thermophore MaxHeat Model 155, found the amperage ranging from (b)(4) to (b)(4) for testing of final assembly for (b)(4) heating pads produced that day. This was higher than the (b)(4) listed as “MAX AMPS” on S10474 “Testing Amperage Chart”, dated August 13, 2014. Product was released for shipment and distribution.
The adequacy of your firm’s response cannot be determined at this time. You have indicated you are developing a new procedure for device acceptance. This is a planned action that we cannot evaluate at this time.
7. Failure to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. According to the Purchasing procedure, dated July 24, 2013, “(b)(4)”. Specifically, your firm made a design change to use high durability SVT cord for the Thermophore Classic (model #: 055, 056, 077, 095, 096, 097) heating pads. A new supplier was approved on the new SVT cord supplier. The S10075 Vendor Evaluation Form documents a sample was received November 25, 2013 and was signed by management as approved. However, you did not have any objective evidence to show that the sample met the specified requirements.
The adequacy of your firm’s response cannot be determined at this time. You have indicated you will create separate work instructions for evaluating new vendors and existing vendors. This is a planned action that we cannot evaluate at this time.
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 the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 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 occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or 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: Catherine V. Quinlan, Compliance Officer, Food and Drug Administration at 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about the contents of this letter, please contact Ms. Quinlan at (313)393-8153.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s 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 bring the products into compliance.
Art O. Czabaniuk
Detroit District Office
Copy (via UPS) to: Randy A. Newsome
Vice President & General Manager
Battle Creek Equipment Company
702 S. Reed Road
Fremont, IN 46767