- Anybattery, Inc.
- Issuing Office:
- Minneapolis District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Minneapolis District Office |
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100 FAX: (612) 334-4142
April 29, 2015
Via UPS Overnight Delivery
Refer to MIN 15 - 10
Edward J. Speegle
Chief Executive Officer
2605 160th Street West, Unit 116
Rosemount, Minnesota 55068
Dear Mr. Speegle:
During an inspection of your firm, Anybattery, Inc., located at 2605 160th Street West, Unit 116, Rosemount, Minnesota, from October 21 through November 17, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures replacement batteries for medical 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 are intended to affect the structure or 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 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 of the Quality System (QS) regulations found at Title 21, Code of Federal Regulations (21 CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish procedures for corrective and preventive action as required by 21 CFR 820.100(a). Specifically, there is no procedure established for analyzing, investigating, and identifying actions needed to correct and prevent recurrence of nonconforming product and other quality problems through the analysis of processes, work operations, quality audit reports, quality records, complaints, and returned product. Also, records of these CAPA inputs are not maintained.
2. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit which is required by 21 CFR 820.198(a). Specifically:
a. Of the 14 returned goods authorization (RGA)/order form records selected for review, the following RGAs did not contain a documented reason for return and were not evaluated to determine whether the RGA met the formal definition of a complaint.
i. RGA #23001, dated 01/07/2011, for part #7711
ii. RGA #23100, dated 04/05/2011, for parts #7170-3
iii. RGA #24223, dated 01/22/2013, for part #7208
iv. RGA #25068, dated 12/17/2013, for part #4043
v. RGA #25203, dated 03/07/2014, for part #7210
vi. RGA #25358, dated 05/21/2014, for part #7946
b. Data resulting from investigational activities, such as battery analyzer results, for the above RGAs (which were not evaluated to determine whether the RGA was a complaint) were not maintained. For example, the order form for RGA #25203 stated that the returned battery, part #7210, passed the battery analyzer test and was sent back to the customer. There is no record of these battery analyzer test results.
c. Files related to the following requested RGAs could not be located during this inspection.
i. RGA #23135, dated 05/11/2011, for part #7022 (RGA log states that the customer received the battery with a broken fuse.)
ii. RGA #23221, dated 07/21/2011, for part #4551 (RGA log states that the customer wants the broken connectors fixed.)
iii. RGA #23570, dated 10/05/2011, for part #7022 (RGA log states that customer claimed that there was no run time on the battery.)
iv. RGA #23656, dated 12/13/2011, for parts #7170-2
v. RGA #23733, dated 02/16/2012, for part #7946
vi. RGA #23959, dated 07/24/2012, for parts #7170-2
vii. RGA #24633, dated 03/08/2013, for parts #7170-4
viii. RGA #24963, dated 10/09/2013, for parts #7170-3
3. Failure to establish procedures for design control which are required by 21 CFR 820.30(a). Specifically, there is no procedure established to control the design of the assembled replacement batteries in order to ensure that specified design requirements are met. In addition, there are no specifications defined for the components and assembled replacement batteries (excluding minimum voltage and battery chemistry), and no design control activities, such as design inputs, outputs, verification, validation, or changes, have been documented. For example, there is no documentation for battery assembly part #7064 that defines specifications for the battery cell (excluding minimum voltage and battery chemistry), harness, or tubing used to assemble the replacement battery, and no design verification or validation activities have been conducted.
4. Failure to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50. Specifically, there is no procedure established that defines the requirements that must be met by suppliers of components (such as battery cells, harnesses, and wires) for battery manufacturing operations or for suppliers of finished batteries to be relabeled by Anybattery, Inc. Additionally, there is no documentation that suppliers have been evaluated and selected based on their ability to meet specified requirements.
5. Failure to establish procedures for finished device acceptance which is required by 21 CFR 820.80(d). Specifically, an engineering drawing describes the assembly procedure for each assembled battery and defines the final testing requirements, but the results of final test activities to ensure that each battery production lot meets acceptance criteria are not documented. For example, the final step (step (b)(4)) of the engineering drawing for parts #7170-2 states that the assembly is to be tested at (b)(4) minimum, but the results of these final test activities are not documented.
6. Failure to establish procedures for acceptance of incoming product as required by 21 CFR 820.80(b). Specifically, there is no procedure established for the acceptance of incoming components for battery assembly operations (such as battery cells, harnesses, and wires) or for finished batteries that are relabeled by Anybattery, Inc. In addition, records documenting the acceptance of incoming components are not maintained. Examples include:
a. Battery assembly part #7946, lot number 0504121, is composed of (b)(4) battery cells under battery part #6257-2f. There is no incoming inspection procedure or documentation of acceptance activities for these supplied battery cells used in the production of lot number 0504121.
b. Battery part #4713-7 is a finished battery that is supplied to Anybattery, Inc. and relabeled. There is no incoming inspection procedure or documentation of acceptance activities for Anybattery, Inc. lot number 1031143.
7. Failure to establish procedures for device history records as required by 21 CFR 820.184. Specifically, there is no procedure established to ensure that device history records (DHRs) for each assembled battery lot are maintained to demonstrate that devices were manufactured in accordance with the device master records (DMRs). An order form documents the batteries shipped with applicable quantities, part numbers, and lot numbers to individual customers. For example, order form for customer number (b)(4), dated 06/04/2013, identified (b)(4) batteries, part #7946 and lot number 0504121, that were sent to the customer on 06/04/2013. However, there were no DHRs available to document the component lot traceability, date of manufacture, quantity manufactured, quantity released for distribution, acceptance records, and labeling used for each production unit within lot 0504121.
8. Failure to establish procedures to control product that does not conform to specified requirements which is required by 21 CFR 820.90(a). Specifically, there is no procedure established to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product.
9. Failure to establish procedures for management review as required by 21 CFR 820.20(c). Specifically, there is no procedure established for conducting management reviews. In addition, no formal management reviews have been documented within the last three years.
10. Failure to establish procedures for quality audits as required by 21 CFR 820.22. Specifically, there is no procedure established for conducting quality audits. In addition, there is no documentation that internal audits have been conducted within the last three years.
11. Failure to establish procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained which is required by 21 CFR 820.72(a). Specifically, there is no procedure or calibration frequency established for equipment used in the testing of replacement batteries in production as well as finished replacement batteries that are tested and relabeled. In addition, calibration activities have not been performed for this equipment. For example, the voltmeters and battery analyzer units used to test battery voltages and establish final battery acceptance have not been calibrated to ensure that the equipment is suitable for its intended purposes and is capable of producing valid results.
Our inspection also revealed that the replacement batteriesare 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 device 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, failure to develop, maintain and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, your firm acknowledged that it did not have an MDR procedure.
We reviewed your firm’s response dated December 12, 2014, and conclude that it is inadequate. Your firm’s response included an MDR procedure titled “ANYBATTERY INC – MDR PROCEDURE,” undated. After reviewing your firm’s MDR procedure, the following issues were noted:
- MDR PROCEDURE does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
o The definition of the term “MDR reportable event” is inconsistent with the definition of the term in 21 CFR 803.3 and may not allow your firm to correctly identify complaints as reportable events.
o There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
- MDR PROCEDURE does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
o There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
o The procedure, as written, does not specify who makes the decision for reporting events to the FDA.
o There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
- MDR PROCEDURE does not establish internal systems that provide for timely transmission of complete medical device reports to the FDA. Specifically, the following is not addressed:
o Instructions for how to obtain and complete the FDA 3500A form.
o The circumstances under which your firm must submit supplemental or follow-up reports and the requirements for such reports.
o How your firm will submit all information reasonably known to it for each event.
o The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
- MDR PROCEDURE does not describe how your firm will address documentation and record-keeping requirements, including:
o Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
o Systems that ensure access to information that facilitates timely follow-up and inspection by the FDA.
Your firm’s procedure includes references to baseline reports and annual certifications. Baseline reports and Annual Certifications are no longer required and we recommend that all references to a Baseline Report and Annual Certifications be removed from your firm’s MDR procedure (see respectively: 73 Federal Register Notice 53686, dated September 17, 2008; and Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting; Annual Certification; Final rule).
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to the FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
Our inspection also revealed that the replacement batteries are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).
The replacement batteries are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm.
It is the Agency’s position that the replacement batteries fall under the same regulation as the device it intends to support. Therefore, your firm needs to identify exact medical devices its batteries are supporting, search the FDA 510(k) database for Class II medical devices (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm) and submit premarket submissions pertaining to the replacement batteries accordingly. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
For class III devices such as pacemakers and implantable infusion pumps, your firm cannot market its replacement batteries until it receives the appropriate PMA approval. Your firm needs to contact the class III device PMA holder and then the PMA holder will have to submit a PMA supplement for the replacement batteries.
Additionally, your firm was not registered as a medical device manufacturer when the aforementioned inspection began; however, you registered during the inspection. We note that your firm is not in compliance with device listing requirements because you have only listed devices under Product Code MOQ, 21 CFR 878.4820, Surgical instrument motors and accessories/attachments. There are also two other product codes for rechargeable replacement batteries. Product code MOX is for rechargeable batteries for Class II devices and MOY is the product code for rechargeable batteries for Class III devices. You must update your listing to accurately reflect your firm’s current operations.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 deviations 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 15 working days from the date you receive this letter with an update on the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Mr. Philips at (612) 758-7133.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the close out of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations and take prompt action to correct the violations and to bring your products into compliance.
Michael Dutcher, DVM
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