Juan C. Cucchi
Insert Depot, Inc.
5425 NW 24th Street, Suite 204
Margate, FL 33063 U.S.A.
Dear Mr. Cucchi:
During an inspection of your facility located in Margate, Florida on November 07, 2013, through November 19, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical devices, including the Tony Riso 25/30 Multifunction Ultrasonic Scaler. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is 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) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a written response from you dated December 09, 2013, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We acknowledge your assurance to cease manufacturing and distributing new devices and to submit monthly updates documenting your process; however, as of the date of this letter no updates have been received. Additionally,this response is incomplete as you failed to provide documentation of the corrections and/or corrective actions, therefore; your response is inadequate.
The 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(a). For example:
a) A review of your Repair Log of returned product revealed complaints for the following Tony Riso 25/30 Multifunction Ultrasonic Scalers (identified by their device serial number) that were not documented according to your Complaint Handling Procedure, SOP 0004 effective 04/10/13:
- Unit# 070912A, returned on 09/13/13
- Unit # 041513, returned on 07/23/13
- Unit# 061912A, returned on dates 12/06/12, 05/09/13, and 05/27/13
- Unit# 030813, returned on 04/15/2013
b) You failed to review, evaluate, and investigate complaints involving the possible failure of the following Tony Riso 25/30 Multifunction Ultrasonic Scalers (identified by their device serial number) documented on your Repair/Complaint Forms:
- Unit# 012213 recorded on Repair/Complaint Sheet dated 02/15/13 – Complaint listed as, “device stopped working after 2 weeks”
- Unit# M102411A recorded on Repair/Complaint Sheet dated 03/18/13 –Complaint listed as, “unit won’t vibrate”
- Unit# M010912A recorded on Repair/Complaint Sheet dated 03/11/2013 – Complaint listed as, “Fan Doesn’t Work”
- Unit# 040111 recorded on Repair/Complaint Sheet dated 02/05/13 – Complaint listed as, “Shut off when put on Reostat, then stopped completely”
During the inspection, you failed to provide documentation to indicate if an investigation was conducted to determine the cause of these failures, or refer to an investigation already performed for the noted device failures.
2. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, you have not established and maintained procedures for design control of the device identified as the Tony Riso 25/30 Multifunction Ultrasonic Scaler.
3. Failure to establish and maintain corrective and preventive action procedures, as required by 21 CFR 820.100(a). For example, there are no written Corrective and Preventive Action procedures. Although the records for 12 of 18 complaints reviewed during the inspection identified the need for causative or systemic corrective actions; your firm did not provide documentation to establish that any such corrective actions were implemented.
4. Failure to establish and maintain procedures for acceptance activities, including inspections, tests, and other verification activities, as required by 21 CFR 820.80(a). For example, there are no procedures for acceptance activities established for the Tony Riso 25/30 Multifunction Ultrasonic Scaler.
5. Failure to maintain an adequate device master record prepared and approved in accordance with 21 CFR 820.40 as required by 21 CFR 820.181. For example, you do not have a device master record for the Tony Riso 25/30 Multifunction Ultrasonic Scaler that includes or refers to the location of: (a) device specification; (b) production process specifications: (c) quality assurance procedures and specifications: (d) packaging and labeling specifications; and (e) installation, maintenance, and servicing procedures.
6. Failure to maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184. For example, you have not maintained DHRs for the Tony Riso 25/30 Multifunction Scaler.
7. Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e). For example, in addition to the previously cited lack of procedures you have not established written quality system procedures and instructions for the following:
- Nonconforming Product [21 CFR 820.90(a)]
- Purchasing Controls [21 CFR 820.50]
- Process Controls [21 CFR 820.70(a)]
- Management Reviews [21 CFR 820.20(c)]
- Quality Audits [21 CFR 820.22]
- Device Labeling [21 CFR 820.120]
- Identification of product during all phases [21 CFR 820.60]
Our inspection also revealed that your medical 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 (MDR) regulation. The significant violation includes, but is not limited to, the following:
Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, no written MDR procedures were available during the inspection.
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 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 device 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 you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this letter.
Your response should be sent to:
Erica M. Katherine, Compliance Officer
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida, 32751
If you have any questions about the content of this letter please contact: Erica M. Katherine at (407) 475-4731.
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 Form FDA 483, Inspectional Observations (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Elizabeth W. Ormond
Acting Director, Florida District