Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
August 12, 2013
VIA UNITED PARCEL SERVICE
Mr. Eduardo Diaz S.
Deroyal Cientifica De Latinoamerica S.R.L.
Global Park, Box 180-3006, 602 Parkway
La Aurora, Heredia, Costa Rica
Dear Mr. Diaz:
During an inspection of your firm located in La Aurora, Heredia, Costa Rica, on February 25, 2013, through February 28, 2013, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures electrosurgical cutting and coagulation accessory and esophageal stethoscope 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 function of the body.
Our inspection revealed that your esophageal stethoscopes, temperature sensor catheters, and electrosurgical cutting and coagulation accessory devices are misbranded under section 502(t)(2) of the Act 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) Regulation. Significant violations include, but are not limited to:
1. Failure to document in the MDR event file an explanation of why your firm did not submit information required by 21 CFR 803.52 on the FDA Form 3500A, as required by 21 CFR Part 803.18(e). For example: MDR# 9613793-2011-00001 describes a malfunction of your firm’s device, the DeRoyal Push Button Pencil w/ ENT. FDA received the report on March 9, 2011. Your firm’s MDR file for this event did not contain an explanation of why information for Sections G.4 and G.5 on the FDA Form 3500A was not provided to FDA.
2. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17(a). For example, after reviewing your firm’s MDR procedure titled “Medical Device Problem Reporting,” CORP.PRC.004, Rev. J, 4/25/2011, the following issues were noted:
a) CORP.PRC.004, Rev. J, 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:
- The procedure does not include definitions of the terms “become aware,” and “caused or contributed,” found in 21 CFR Part 803.3, and “reasonably suggests,” found in 21 CFR 803.20(c)(1). The exclusion of 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) CORP.PRC.004, Rev. J, does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
- Instructions for how to obtain and complete the FDA 3500A form.
- 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.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
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
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 awarding of contracts.
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 (including any systemic corrective actions) 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. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act, 21 U.S.C. § 351(h), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
A. Verification of the effectiveness of corrective actions is not complete: for Action Point Report #DCLA 12-10-003, the verification only refers to documents that show that changes were requested.
B. Incomplete evaluation of the impact of corrective actions on devices: four Action Point Reports with #'s DCLA 11-05-002, dated 05/31/11; DCLA 12-10-003, dated 10/29/12; DCLA 12-04-001, dated 03/03/11; and DCLA 11-11-001, dated 11/04/11, have no record of the evaluation of the effect of corrective actions on product.
C. Details about corrective actions taken are missing:
i. Action Point Report #DCLA 11-11-001, dated 11/04/11,does not have documentation of when changes were implemented.
ii. Action Point Report #DCLA 12-04-001, dated 03/03/11, related to issues with the (b)(4), does not have documentation of the re-qualification of the (b)(4).
iii. Call #(b)(4), dated 01/27/2011, for (b)(4) during surgical procedures, resulted in a corrective action to prevent recurrence; in this case, there was a repair of the (b)(4), but there is no documentation showing when the changes were implemented or documentation of a re-qualification or other verification of the (b)(4) after repairs.
D. Action Point Report #DCLA-12-03-002 describes a mix-up with the packaging of finished product returned to the plant for rework. The investigation of root cause was not documented fully and the verification of effectiveness was not signed and dated by management.
E. A report for complaint numbers 20532, 20533, and 20534, reported on 01/13/11, notes a preventive action that refers to ECO #(b)(4) and that guidelines implemented should be followed by Manufacturing and Quality Control. Evidence of the verification of effectiveness of the corrective actions was not documented.
2. Failure to establish and maintain adequate procedures for documentation of rework and reevaluation activities of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 90(b)(2). For example: the defect codes assigned to the (b)(4) steps during production are used in the final inspection step when recording (b)(4) product on form DCLA.FRM.004, Rev.9/99, "(b)(4).” Defect codes designated as (b)(4) are used interchangeably to also document non-conformance on form DCLA.FRM.O11, Rev. Sep/2010.
3. Failure to periodically inspect environmental control systems to verify that the system, including necessary equipment, is adequate and functioning properly, and failure to document and review these activities, as required by 21 CFR 820.70(c). For example: the procedure for monthly environmental monitoring of the "Controlled Production Area" was not followed for the months of (b)(4) and (b)(4) 2012 and (b)(4) 2013. Nonconformance reports for "alert action limits" were not completed for (b)(4) and (b)(4) 2012. Temperature and humidity monitoring was not recorded for (b)(4) 2012 and (b)(4) 2013.
4. Failure to designate an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part, as required by 21 CFR 820.40(a). For example:
a. The rework procedure for this plant location, Document #DCLA.QLP.017, Rev. G, effective 05/28/10, does not describe the procedure that is currently being used to reprocess product returns and non-conforming product.
b. The Control of Non-Conforming Product Corrective and Preventive Action Procedure, DCLA.QLP.018, Rev. H, effective 09/03/10, Section 9.8, describes the incorrect reprocessing procedure used during production.
5. Failure to document the dates and results of quality audits and reaudits, as required by 21 CFR 820.22. For example, Section 8.2 of Internal Audit Procedure, CORP.PRC.003, requires (b)(4) Facility Level Internal Audits, but there is no documentation that these audits were performed in (b)(4).
6. Failure of management with executive responsibility to establish its policy and objectives for, and commitment to, quality, as required by 21 CFR 820.20(a). For example, the Quality Manual, CORP.QLM.001, Rev. N, effective March 12, 2012, does not document the final approval by the Corporate President.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #406127 when replying. If you have any questions about the contents of this letter, please contact: LaShanda Long, Chief, General Surgery Devices Branch at 301-796-5465 or Fax: 301-847-8137.
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.
Steven D. Silverman
Office of Compliance
Center for Devices and