WARNING LETTER
Whitehall/Div of Acorn Engineering Co MARCS-CMS 525297 —
- Recipient:
- Whitehall/Div of Acorn Engineering Co
United States
- Issuing Office:
- Los Angeles District Office
United States
| |
Office of Medical Device and Radiological Health Operations Division 3 West 19701 Fairchild Irvine, CA 92612 |
WARNING LETTER
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
July 12, 2017
WL #525297-17
Donald L. Morris, CEO and Owner
Whitehall/Division of Acorn Engineering Company
15125 Proctor Avenue
City of Industry, CA 91746-3327
Dear Mr. Morris:
During an inspection of your firm located in City of Industry, California, from March 6 through March 23, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures whirlpool immersion hydro therapy devices and dry heat therapy devices. 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 your hydro therapy devices and dry heat therapy devices are adulterated within the meaning of section 501(h)[21 U.S.C. § 351(h)] of the Act, 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 (CGMP) requirements for devices which are set forth in the Quality System Regulation, as specified in Title 21, Code of Federal Regulations, Part 820.
We received a response from David Young, your Vice President of Engineering, dated April 13, 2017, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to your firm on March 23, 2017. 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 adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198.
For example, your complaint handling procedures, QMP-20, Feedback, Revisions B and C, as well as QMP-82-09, Feedback, Revision A, which were in effect from 12/23/14 through the conclusion of the inspection, do not require all complaints to be evaluated to determine if they represented an event that is required to be reported to FDA under 21 CFR Part 803. In addition, these procedures do not require maintaining records documenting the dates and results of complaint investigations, reasons when no investigation is conducted and documentation of the individual responsible for making the decision not to investigate, and that any replies to the complainant be maintained.
We reviewed Mr. Young’s response dated April 13, 2017, and find it inadequate. He provided updated complaint handling procedures, QMP-20, Complaint Handling, Rev. D, dated March 23, 2017. These procedures do not address the deficiencies referenced above.
2. Failure to investigate the possible failure of a device to meet any of its specifications where necessary, as required by 21 CFR 820.198(c).
For example, the following are representative of complaints involving the failure of a device to meet its specifications that were not investigated, or where documentation of an investigation was not maintained. Please be advised that this is not an all-inclusive list:
Case (b)(4), dated (b)(4), referenced a Dry Heat Therapy device where the unit did not heat up, was repaired, and after a few months of use, it did not work. A technician went to the customer to repair the unit. The repairs lasted a week, and the device failed again. The unit was replaced. The complaint file states the device was sent to your R&D lab for evaluation on 1/13/2017. Your firm did not document this evaluation/investigation.
Case (b)(4), dated (b)(4), referenced a Hydrotherapy device where the customer reported the motor got quieter and quieter and started to smell like it was burning. The customer was sent a new unit. The complaint file states the device was sent to your R&D lab for evaluation on 2/7/17. Your firm did not document this evaluation/investigation.
Case (b)(4), dated (b)(4), referenced a Hydrotherapy device where the customer reported the motor had seized up; the customer wanted a replacement. The defective unit was brought back for testing and evaluation. Your firm did not document this evaluation/investigation.
Case (b)(4), dated (b)(4), referenced a Hydrotherapy device where the customer reported a defective turbine. A replacement turbine was sent to the customer. Your firm did not document any investigation as to the root cause of the turbine failure.
Case (b)(4), dated (b)(4), referenced a Splint Pans Therapy device where the temperature was reported to rise above the boiling point. Your firm did not document any investigation as to the root cause of this device failure.
The following complaints represent Hydrotherapy devices where the GFCI tripped when the units were turned on. No investigations were made for these device failures:
Case (b)(4)
Case (b)(4)
Case (b)(4)
Case (b)(4)
Case (b)(4)
Case (b)(4)
We reviewed Mr. Young’s response dated April 13, 2017, and find it inadequate. He provided updated complaint handling procedures, QMP-20, Complaint Handling, Rev. D, dated March 23, 2017, but did not address whether a retrospective review of complaints would be conducted, nor did the response include corrective actions to ensure future complaints would be investigated.
3. Failure to establish a design history file, as required by 21 CFR 820.30(j). For example, your firm did not establish a design history file for your Thermo Therapydry heat therapy devices, your Little Champ Hydro Whirlpool devices, or your Paraffin Bath devices.
We reviewed Mr. Young’s response dated April 13, 2017, and find it inadequate. He stated your firm had issued a formal internal CAPA for this observation, and was in the process of “collecting all relevant documents into a secure and easily achievable and retrievable location” that would be complete by 5/29/17. No further information was provided.
4. Failure to adequately establish procedures for design change, as required by 21 CFR 820.30(i). For example, in July 2016, your firm implemented design changes to the turbine used in your Hydrotherapy devices, which included different component parts and assembly changes such as a newly designed motor , motor cover assembly, motor base, brackets, and fuses. Your firm did not maintain documentation to demonstrate that the design changes were reviewed and approved before their implementation.
We reviewed Mr. Young’s response dated April 13, 2017, and find it inadequate. He stated your firm initiated a formal CAPA for this process, but the response did not include the CAPA. He stated your current procedure is being reviewed for adequacy and will be revised to be in full compliance with FDA requirements. The response did not address whether you would be performing the activities required under 21 CFR Part 820.30(i).
5. Failure to adequately establish procedures for design transfer, as required by 21 CFR 820.30 (h). For example, the design changes to the turbine used in your Hydrotherapy devices were not correctly translated to production specifications. The production work instructions that were being used were obsolete.
We reviewed Mr. Young’s response dated April 13, 2017, and find it inadequate. He cited the CAPA referenced for the correction of item (4) in this letter, but did not include the CAPA. The response did not address whether you would ensure the design changes implemented for your Hydrotherapy devices will be correctly translated into production specifications.
6. Failure to adequately maintain a device master record, as required by 21 CFR 820.181. For example, the Engineering Technical File for your Whirlpool Bath Medical Device System, (b)(4), dated (b)(4), does not maintain work instructions, specifications, including acceptance criteria or quality assurance equipment used in the manufacturing of these devices. In addition, firm management stated your firm does not maintain a device master record for your Thermo-Therapy dry heat devices.
We reviewed Mr. Young’s response dated April 13, 2017, and find it incomplete. In this response, he cited the CAPA referenced for the correction of item (3) in this letter, but did not include the CAPA. The response referenced the firm is working towards collecting and placing all relevant documents into a secure and easily achievable and retrievable location on your internal network. The stated completion date for this was June 28, 2017. No further information was provided.
7. Failure to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures, as required by 21 CFR 820.75(a). For example, your firm has not validated the welding processes for automatic and hand welding used in the manufacturing of your Hydro Therapy stainless steel tubs.
We reviewed Mr. Young’s response dated April 13, 2017, and find it incomplete. He stated your firm would conduct a formal validation of these processes, with completion date of May 29, 2017. No further information was provided.
8. Failure to maintain a device history record, as required by 21 CFR 820.184. For example, your firm does not maintain device history records for your Thermo-Therapy dry heat devices.
We reviewed Mr. Young’s response dated April 13, 2017. The corrective actions taken in response to deficiencies in device history records for your firm’s Hydrotherapy devices that were documented on Form FDA-483, dated March 23, 2017, appear adequate. His response is inadequate in that your firm did not reference any corrective actions to ensure device history records are maintained for your Thermo-Therapy dry heat devices.
9. Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c). For example, your procedure, QM-04, Management Review, Rev. B requires your firm to conduct management reviews at least once a year. Your firm failed to conduct management reviews in 2014 and 2015.
We reviewed Mr. Young’s response dated April 13, 2017, and find it inadequate. He referenced that the quality management system was the focus of discussions (b)(4), and that a formal management review was not conducted in 2014 or 2015. He did not reference whether a management review would be conducted for 2017.
10. Failure to adequately establish procedures for training and identifying training needs, as required by 21 CFR 820.25(b). For example, your firm’s Quality Manager performed an internal audit of your firm’s quality system in 2016. Your firm did not maintain documentation that the auditor was trained in applicable FDA regulations pertaining to medical devices, such as 21 CFR Parts 820, 803 and 806.
Your firm’s response did not address this inspectional observation.
Our inspection also revealed that your firm’s immersion hydrobaths are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Significant deviations include, but are not limited to:
1. Failure to develop, maintain and implement MDR procedures as required by 21 CFR 803.17.
For example: during the inspection of your firm, firm management acknowledged that your firm did not develop an MDR procedure and the firm was unaware of the FDA regulations.
We reviewed Mr. Young’s response dated April 13, 2017 and find it inadequate. Your firm developed and submitted a copy of its MDR procedure titled: “Medical Device Reporting (FDA)”, SOP-QC-08, Revision A, dated March 17, 2017. After reviewing your firm’s MDR procedure, the following issues were noted: SOP-QC-08, Revision A does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. The procedure does not include a reference for the submission of MDR reportable events using the mandatory 3500A or electronic equivalent.
b. Although the procedure includes references to 5 day reports, it does not specify work days, respectively.
c. How your firm will submit all information reasonably known to it for each event. Specifically, which sections of the 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow up within its firm.
Your firm should also adjust its MDR procedure accordingly to include a process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the Federal Register on February 14, 2014. In addition, your firm should establish an eMDR account in order to submit MDRs electronically. Information about the Final Rule for eMDR and the eMDR set-up process can be found on the FDA website at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR%E2%80%93ElectronicMedicalDeviceReporting/default.htm .
2. Failure to report no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
For example, complaint (b)(4) suggests your firm’s device malfunctioned (i.e. unit was smoking), resulting in the water temperature to reach 200 degree Fahrenheit. Your firm did not submit an MDR for this event.
We reviewed Mr. Young’s response dated April 13, 2017 and find it inadequate. Your firm did not submit an MDR for the referenced complaint and it noted that plans to retroactively collect all relevant data regarding potential MDR reportable complaints will be completed by May 1, 2017.
If your firm wishes to discuss the MDR related issues noted above, please contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
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 (15) 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.
If you have any questions about the content of this letter, contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or raymond.brullo@fda.hhs.gov.
Please identify your response with FEI 1000150265.
Send your reply to:
Kelly D. Sheppard
Compliance Branch Director
US Food and Drug Administration
Division 3/West
Office of Medical Device and Radiological Health Operations
19701 Fairchild
Irvine, CA 92612-2506
Sincerely,
/S/
Shari J. Shambaugh
Acting Program Division Director