- Vention Medical
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
JUL 1, 2014
VIA UNITED PARCEL SERVICE
Zona Franca Metropolitana
Barreal de Heredia
Dear Mr. Villalobos:
During an inspection of your firm located in Barreal de Heredia, Costa Rica, on March 3, 2014, through March 6, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures thermotherapy systems, cord blood processing systems, negative pressure wound therapy equipment, and various types of catheters. 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.
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 an undated, unsigned response on March 26, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. 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 ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).
For example, your firm’s Cleaning and Sanitation procedure, (b)(4), describes methods for maintaining cleanliness of the controlled environment that include cleanrooms, gowning areas, and quality labs. However, according to Mr. Harold Gomez, Quality Director, your firm has not validated in-house test methods for maintaining the cleanliness of the controlled environment.
The adequacy of your firm’s response cannot be determined at this time because as of the March 26, 2014, response, your firm had not yet completed the corrective actions that were intended to address the above deficiencies.
2. Failure to establish and maintain procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality and failure to periodically inspect environmental control systems to verify that the system is adequate and functioning properly, as required by 21 CFR 820.70(c). For example:
a. Your firm’s environmental control procedure titled Controlled Environmental Area Classification & Monitoring, (b)(4), revision C, is deficient. For example:
i. The procedure does not address how your firm’s clean air system will be maintained.
ii. At the time of the inspection, the investigator noted a gap approximately (b)(4) to the uncontrolled (b)(4) room. According to Mr. Jonathan Elizondo, Facilities/Maintenance Manager, no action has been taken to fix the gap.
b. Viable and non-viable particulate counts for the controlled environment are not documented. For example:
i. Section 8.4 of procedure (b)(4) requires particulate counts to be documented in Form (b)(4). However, Form (b)(4) was not completed for the non-viable particulate counts performed on April 24, 2013, April 29, 2013, September 14, 2013, and November 6, 2013.
ii. Non-viable particulate counts dated April 24, 2013, April 29, 2013, and November 6, 2013, are required to be documented in (b)(4), revision H. However, your firm failed to meet this documentation requirement.
c. Four non-viable airborne particle samples failed to meet the acceptable limit. However, your firm failed to re-sample areas associated with the failures and open Nonconforming Event Reports per section 8.5 of the procedure (b)(4).
The adequacy of your firm’s response cannot be determined at this time because, as of the March 26, 2014, response, your firm had not yet completed the corrective actions that were intended to address the above deficiencies.
3. Failure to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, as required by 21 CFR 820.70(g)(1). For example, according to Mr. Jonathan Elizondo, Facilities/Maintenance Manager, your firm has not established a maintenance schedule for the Heating, Ventilating and Air Conditioning system (HVAC system) used for the controlled environment.
We reviewed your firm’s response and conclude that it is not adequate. Your firm initiated CAPA1403004 to address the above deficiencies. As part of the corrective actions, your firm plans to update its Maintenance Procedure, (b)(4), to include specific maintenance activities. However, your firm’s response did not address personnel training per the revised procedure.
4. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
a. Your firm’s Corrective and Preventive Action procedure, (b)(4), does not address the following:
i. Investigating the cause of nonconformities relating to products and processes;
ii. Employing appropriate statistical methodology where necessary to detect recurring quality problems;
iii. Identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems.
b. According to Mr. Harold Gomez, Quality Director, data from monthly environmental samples of (b)(4) were not analyzed to identify the existing and potential cause of nonconformances related to airborne and surface particulate exceeding the alert limit.
c. Your firm’s report on CAPA 301301006 concluded that the CAPA was effective. However, the report did not include employee training as part of the corrective action and did not verify whether the employees were following procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm plans to revise its CAPA procedure and review corrective actions to evaluate if re-validations would be required. However, the March 26, 2014, response does not include evidence of implementation of any corrective actions. Additionally, the response did not address whether personnel training will be conducted per revised procedure.
5. Failure to document all CAPA activities and their results, as required by 21 CFR 820.100(b). For example, per CAPA 301209011, the following CAPA remediation activities were not documented:
a. The addition of (b)(4) to the (b)(4) area and (b)(4) area in the (b)(4);
b. Locking automatic doors from the (b)(4) to the (b)(4) room; and
c. Installing pass-through doors.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not address why these activities were not documented. In addition, your firm did not consider a systemic corrective action to include a retrospective review of other CAPAs to ensure that these reports were adequately documented.
U.S. 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 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 fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including 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 action (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. Please provide a translation of documentation not in English to facilitate our review.
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 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #427910 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at telephone 301-796-5587 or fax 301-847-8139.
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
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