WARNING LETTER
Carroll-Baccari, Inc. dba Mavidon Medical Products
MARCS-CMS 598514 —
April 17, 2020
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Timothy J. Carroll
Recipient Title
President
Carroll-Baccari, Inc. dba Mavidon Medical Products
110 Commercial Blvd
Flat Rock
,
NC
28731
United States
tim@mavidon.com
Issuing Office:
Division of Medical Device and Radiological Health Operations Central
United States
WARNING LETTER
CMS # 598514
April 17, 2020
Dear Mr. Carroll:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 6625 White Drive, Riviera Beach, Florida on October 2, 9-11 & 16, 2019. During the inspection, FDA investigators determined that your firm is a medical device manufacture of LemonPrep, PediaPrep, and CardioPrep abrasive skin prepping lotions and gels. 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 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response on November 4, 2019 from you, concerning our investigators observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on October 16, 2019. We address the 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(b). For example:
A. Your procedure SOP 14-02, COMPLAINT MANAGEMENT, Rev F, Issue Date 12/4/18 which governs your complaint handling activities requires in section 6.1.5 that each complaint be evaluated for reportable status and the decision recorded on the complaint form. During evaluation of your complaint handling activities and documentation, Complaint 19-001, received on 8/2/19, was reviewed. Complaint 19-001 alleges that tubes of LemonPrep manufactured by your firm were contaminated by Burkholderia cepacia microorganism. As of 10/11/19, the final Medical Device Reporting (MDR) determination block on the Complaint 19-001 form remained blank; and the questions of whether a death or serious injury had occurred, whether the devices malfunctioned, or whether the device had caused or contributed to a death or serious injury were all answered “No”. Your firm’s recall letter, dated 9/27/19, resulting from the incident in this complaint states the firm received one report of adverse event in a neonate related to the LemonPrep product subject to the recall.
B. The record for Complaint 19-001, received 8/2/19, only states tubes of LemonPrep were found to be contaminated with Burkholderia cepacia; but does not include or refer to other relevant details of the complaint including whether any patients were affected.
C. Procedure SOP 14-02, COMPLAINT MANAGEMENT, Rev F, Issue Date 12/4/18 does not include the requirement that reportable complaints be evaluated to determine if the device failed to meet specifications; and if the device was being used for treatment or diagnosis.
Complaint handling deficiencies were previously communicated to your firm in our 2014 FDA 483.
We reviewed your firm’s response and find it inadequate. You opened a CAPA to address the deficiencies. You updated your written complaint management procedure but failed to address deviations cited for Complaint 19-001 that were identified in the observation. We are unable to determine the implementation of your firm's corrective actions. A follow-up inspection by FDA is necessary to verify compliance.
(2) Failure to adequately establish procedures for the acceptance of in-process product, as required by 21 CFR 820.80(c). Specifically, your firm has not defined or documented any acceptance criteria for the quality of the
(b)(4)
, used in the manufacture of your LemonPrep and PediaPrep skin prepping lotions.
Deficiencies for failing to establish acceptance procedures were previously communicated to your firm in our 2008 Warning letter and 2014 FDA 483.
We reviewed your firm’s response and find it inadequate. You opened a CAPA to address the deficiency. You cite the lack of process validation for your
(b)(4)
as the reason for not establishing acceptance criteria for
(b)(4)
. Acceptance procedures were not provided for review and process validation has not yet been accomplished. Your firm’s corrective actions are still in progress and a follow-up inspection by FDA is necessary to verify compliance.
(3) Failure to adequately establish process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 CFR 820.70(a). Specifically,
A. Your firm does not have documentation that the
(b)(4)
that
(b)(4)
used in your LemonPrep and PediaPrep skin prepping lotions met installation and performance qualification requirements.
B. Your firm has not defined or documented the instructions for taking the production samples (tested prior to batch release) and the reserve samples for your skin prepping lotions including the size and method of collection.
Process validation deficiencies were previously communicated to your firm in our 2014 FDA 483.
We reviewed your firm’s response and find it inadequate. You opened a CAPA to address the deficiencies and committed to validating your manufacturing process. You failed to validate your manufacturing process and establish process controls prior to manufacturing and release of finished product. Additionally, process control procedures were not provided for review. Your corrective action remains in progress and a follow-up inspection by FDA is necessary to verify compliance.
(4) Failure to adequately establish schedules for the adjustment, cleaning, and other maintenance of equipment, as required by 21 CFR 820.70(g)(1). Specifically, your firm has not defined or documented the maintenance requirements for the
(b)(4)
your LemonPrep and PediaPrep skin prepping lotions;
(b)(4)
.
We reviewed your firm’s response and find it inadequate. You opened a CAPA to address the deficiencies. You cite the lack of process validation for
(b)(4)
as the reason for not establishing schedules for the adjustment, cleaning, and maintenance of equipment. Written equipment maintenance procedures for your
(b)(4)
were not provided. We are unable to determine the implementation of your firm's corrective actions where no documents were provided for review. A follow-up inspection by FDA is necessary to verify compliance.
(5) Failure to adequately 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, your firm’s procedure SOP 06-01, PURCHASING CONTROLS, Rev E, Issue Date 8/30/17 requires the qualification and approval of suppliers that potentially impact product quality. Your firm has not qualified
(b)(4)
for your skin prepping lotions and will conduct routine maintenance on
(b)(4)
.
Purchasing control deficiencies were previously communicated to your firm in our 2014 FDA 483.
We reviewed your firm’s response and find it inadequate. You opened a CAPA to address the deficiency but failed to provide documentation to demonstrate that the vendor responsible for
(b)(4)
is qualified and approved by your firm. We are unable to determine the implementation of your firm's corrective actions where documents are not provided for review. A follow-up inspection by FDA is necessary to verify compliance.
(6) Failure to adequately establish procedures to control labeling activities as required by 21 CFR 820.120). Specifically,
A. The Device Master Records for your LemonPrep and PediaPrep skin prepping lotions, distributed in 4-oz tubes or 9.9-gram single-use cups, do not include the specifications for setting the expiration date periods applied to the label of final packaged devices.
B. You reported the current shelf-life for the PediaPrep is currently 30 months as is programmed in the
(b)(4)
. However, finished device inventory and manufacturing records for final packaged PediaPrep lot 31238 EXP 2022-09-18 of 3-pk/3 tubes/4-oz each manufactured and released on 9/18/19 has an incorrect 36-month shelf-life. PediaPrep lot 31238 EXP 2022-09-18 has been distributed.
C. Your firm does not currently maintain any documentation to support the current 24-month and 30-month expiration dates applied to the labels of your LemonPrep and PediaPrep skin prepping lotions respectively.
Labeling deficiencies were previously communicated to your firm in our 2014 FDA 483.
We reviewed your firm’s response and find it inadequate. You opened a CAPA to address the deficiency and discussed the need for validating the manufacturing process. You failed to provide documentation to support the current expiration dates. Additionally, no procedures for the control of labeling activities were provided for review. We are unable to determine the implementation of your firm's corrective actions. A follow-up inspection by FDA is necessary to verify compliance.
(7) Failure to adequately establish procedures for corrective and preventive action, as required by 820.100(a). Specifically, your firm’s procedure SOP 14-01, CORRECTIVE AND PREVENTIVE ACTION, Rev A, Issue Date 6/25/14 does not ensure identified quality system deficiencies are investigated for root cause; and corrective actions are identified, implemented, and verified or validated. For example, the 2014 FDA inspection identified: 1) the manufacturing process for LemonPrep, including the
(b)(4)
was not validated; and 2) there was no data to support the expiration dates applied to the labels of your medical devices manufactured and distributed by your firm, including the
(b)(4)
and LemonPrep skin prepping lotion. The current inspection revealed there is no documentation of the validation of
(b)(4)
; and there is no documentation supporting the 24-month expiration date applied to the LemonPrep; and the 30-month expiration date applied to the PediaPrep products.
We reviewed your firm’s response and find it inadequate. You opened a CAPA to address the deficiencies but failed to provide documentation to demonstrate that repeat deficiencies identified in 2014 and the current inspection have been corrected. Your corrective actions remain in progress. A follow-up inspection by FDA is necessary to verify compliance.
(8) Failure to maintain document control procedures, as required by 820.40. Specifically, your procedure SOP 05-01, DOCUMENT AND DATA CONTROL, Rev E, Issue date 9/20/18 which governs your document control activities states in section 4.2.1 that all document changes including product specification must be reviewed, approved, and documented through an Engineering Change Order. For example:
A. During review of manufacturing records for your PediaPrep skin prepping lotion we observed final packaged lots:
(b)(4)
on
(b)(4)
with a 24-month expiration date in the format 2020/01;
(b)(4)
on
(b)(4)
with a 24-month expiration date with the format 2020/07; and
(b)(4)
manufactured on
(b)(4)
with a 30-month expiration date in the format 220326. Engineering Change Orders were not available to document the approval of the expiration dates and format changes.
B. The Device Master Record (DMR) for your LemonPrep skin prepping lotion does not contain the latest version of the label used in production. The obsolete labels in the DMR do not include the UDI or your firm’s current address.
Document control deficiencies were previously communicated to your firm in our 2014 FDA 483.
We have reviewed your firm’s response and find it inadequate. You opened a CAPA to address the deficiencies. Although you commit to reviewing device history records (DHRs), updating document control procedures, and retraining employees, you failed to address the deviation cited for the DMR for your LemonPrep skin prepping lotion. Additionally, updated document control procedures and other relevant documentation were not included. We are unable to determine the implementation of your firm's corrective actions where no documents were provided for review. A follow-up inspection by FDA is necessary to verify compliance.
This inspection also revealed that these devices 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 respecting 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 violations include, but are not limited to, the following:
(9) Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “Complaint Management”, SOP 14-02, Revision: F, dated 12/04/2018, the following deficiencies were noted:
A. The 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, as required by 21 CFR 803.17(a)(1). For example, the procedure omits definitions of the terms “become aware”, “caused or contributed”, and “malfunction” found in 21 CFR 803.3. The exclusion of the definitions for these terms from the procedure 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).
B. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, the following are not addressed:
i. Instructions for how to obtain and complete the FDA 3500A form.
ii. The procedure includes 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. However, based on FDA’s records your firm have not been approved for a production account for your eMDR submission. Your firm needs to follow the instructions located at:
iii. https://www.fda.gov/medical-devices/emdr-electronic-medical-device-reporting/how-enroll-emdr-program to complete the eMDR enrollment process in order to receive its production account.
iv. 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 your firm.
C. The procedure does not describe how your firm will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b), including systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
In addition, your firm’s procedure includes references to baseline reports. Baseline reports are no longer required, and we recommend that all references to a baseline report be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008). Also, your firm’s procedure includes references to annual certifications. Annual certifications are no longer required, and we recommend that all references to an Annual certification be removed from your firm’s MDR procedure (see: Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting; Annual Certification; Final rule).
We reviewed your firm’s response dated November 4, 2019 and concluded that it is not adequate. Your firm’s response included a revised document titled “Complaint Management”, SOP 14-02, Revision: G, dated October 21, 2019, which included a definition of “malfunction”, but did not address other noted deficiencies.
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, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. If you believe that your products are not in violation of the Act, please respond to FDA with your reasoning and any supporting information for our consideration.
Our inspection also revealed deficiencies under 21 CFR 803.50(a)(2). Specifcally, failure to submit a report to FDA 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.
For example, the information included for Complaint No. 19-001 reasonably suggests your firm’s LemonPrep malfunctioned (e.g. contamination with Burkholderia cepacia). Per the 1995 Preamble, a malfunction is reportable if the manufacturer takes, or would be required to take, an action under section 518 or 519(g) of the FD&C as a result of the malfunction of the device or other similar devices. (Refer to 1995 Federal Register Volume 60, Number 237, Page 63585. Please note that the preamble reference is section 519(f), but the appropriate designation for the section is now section 519(g) due to amendments to the FD&C Act). FDA determined that your firm’s field action Z-0368-2020 conducted for its same device met the criteria under the 1995 Preamble. The information in the complaint appears to indicate that a death or serious injury may be likely to occur if the malfunction were to recur. Your firm became aware of the event on August 2, 2019 but didn’t submit an MDR for the referenced event.
We reviewed your firm’s response dated November 4, 2019 and concluded that it is not adequate. Your firm’s response noted that it planned to address the noted deficiency. However, your firm did not provide evidence of the planned systemic correction actions, including a retrospective review of all adverse events in accordance with its revised MDR process.
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.
If you have questions regarding any issues in this letter, please contact Compliance Officer, Wendy Blame at
334-273-4789
Ext 101 or at wendy.blame@fda.hhs.gov. Please send your reply electronically to Melissa Michurski, Director of Compliance Branch, oradevices2firmresponse@fda.hhs.gov.
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.
Sincerely,
/S/
Blake Bevill, M.S.
Program Division Director
Office of Medical Device and Radiological Health
Division 2 - Central
Content current as of:
04/28/2020
Regulated Product(s)
Medical Devices