- Criticare Systems (Malaysia) Sdn. Bhd.
- 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|
White Oak Building 66
Silver Spring, MD 20993
JAN 15, 2015
VIA UNITED PARCEL SERVICE
Criticare Systems (Malaysia) Sdn. Bhd.
No.19 Jalan Mega 1/8
Taman Perindustrian Nusa Cemerlang
79200 Nusajaya, Johor
Dear Mr. Jambunathan:
During an inspection of your firm located in Johor, Malaysia, on September 15 through September 19, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures automated external defibrillators (AEDs). 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 a response from you dated October 31, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. Your firm’s response dated November 28, 2014, was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The November 28, 2014, response will be evaluated, along with any other written material provided, in response to the violations cited in this Warning Letter. These violations 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, your firm’s corrective and preventive action (CAPA) procedure, CSMSOP8.5-2.1, Rev. D., requires conducting audits to evaluate the effectiveness of corrective actions. However, your firm did not conduct audits for the vendor corrective actions VCAR-CSI-Oct13-001 and VCAR-CSI-Dec13-001.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not indicate how it will ensure that personnel follow your firm’s CAPA procedure requirements. In addition, the response did not address whether your firm plans to retrospectively review CAPA reports to ensure that the CAPA activities are adequately implemented.
2. Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm’s complaint handling procedures, CSMSOP 8.5.1-2 Rev. A. and CSMOP 7.2.3-1 Rev. D., do not include the following:
i. Requirements for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications to be investigated when necessary.
ii. Requirements for maintaining the records of investigation, including the date that the complaints are received.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not address the procedural deficiencies or missing documentation noted. Additionally, your firm did not indicate whether it plans to retrospectively review complaint files to ensure that the complaints are evaluated and investigated.
3. Failure to maintain a record of investigation, when an investigation is made, by the formally designated unit, as required by 21 CFR 820.198(e). For example:
a. Your firm did not conduct an investigation for Customer Feedback (b)(4) or document a reason for not investigating this complaint in the CAR Form.
b. Your firm did not document the results of investigation for the following complaints involving:
i. Incorrect installation of the insulator used in AED speaker modules;
ii. Incorrect placement of the battery harness wire used for a G3 AED unit;
iii. Unidentified white powder inside a G5 AED unit;
iv. Omission and tearing of the tamper proof sticker on a G5 AED unit; and
v. An electrode peg being shorter than the other electrode peg on a G5 AED unit.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not address the lack of investigation results documentation. In addition, your firm did not indicate whether it plans to retrospectively review complaint files to ensure that the records of the investigations are adequately maintained.
4. Failure to establish and maintain procedures for changes to a specification, method, process, or procedure, as required by 21 CFR 820.70(b). For example:
a. Your firm’s process change procedure, CSMSOP 7.5.1-2, Rev. D., does not have the requirement for verification or, where appropriate, validation of changes made to processes before implementation.
b. Your firm’s process change requests (PCRs), PCR-CSC-514-003, PCRCSC-513-002, and PCR-CSC-113-001-D, do not include the verification or validation of the changes identified on the PCRs or the rationale for why such verification or validation was not required.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide revised process change procedure and personnel training records on the revised procedure. Your firm did not address the lack of verification or validation issue. Additionally, your firm did not indicate whether it plans to retrospectively review process changes to ensure that the changes were implemented with proper change controls. Finally, your firm did not evaluate if the lack of change controls may have led to nonconforming products in distribution.
5. Failure to establish and maintain procedures to ensure that all corrective and preventive action activities are documented, as required by 21 CFR 820.100(b). For example, your firm did not document the following CAPA actions:
a. Verification and validation activities for CAPA report CAR-CSI-June12-001, involving duplicate serial numbers on the G3 AED units;
b. An effectiveness check for supplier corrective action report (b)(4) Nov13-002, involving the use of incorrect LED colors on the G5 AED units; and
c. A supplier corrective action report, linked to CAPA report (b)(4) Apr13-005 on the NVI indicator for the G5 AED units.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not indicate how it will ensure that relevant personnel understand and follow the requirements specified in your firm’s CAPA procedure. In addition, your firm did not indicate whether it plans to retrospectively review CAPAs to ensure proper documentation of CAPA activities.
6. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example:
a. Your firm’s supplier control procedure, CSMSOP 7.4.1-1, Rev. F., does not:
i. Define the type and extent of control to be exercised over the received product, services, suppliers, contractor, and consultants, based on the evaluation results;
ii. Specify the frequency and the type of supplier audit that needs to be performed; and
iii. Ensure that the deficiencies or comments identified in your firm’s prior audits are verified. According to your firm representative, if the follow‑up audit does not include the same comments from the prior audit, then the deficiencies are considered resolved. However, this verification step is not included in your firm’s procedure.
b. Your firm has no documentation indicating that comments from previous audits have been addressed in your firm’s follow-up audits for the following:
i. Your firm’s 2013 audit of (b)(4), which identified three comments: lack of incoming inspection record, lack of training for one year, and lack of data collection for final verification; and
ii. Your firm’s 2012 audit (b)(4), which noted that an acceptance receiving stamp should be on materials.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not address the deficiencies with your firm’s procedures. In addition, your firm did not address whether it plans to retrospectively review supplier contracts and audit reports to ensure that adequate supplier controls have been established.
7. Failure to establish and maintain procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm failed to maintain personnel training records. Specifically, your firm does not have training records for at least one operator on work instruction CSI(b)(4) Revision D., for (b)(4) and (b)(4).
The adequacy of your firm’s response cannot be determined at this time. Your firm’s response indicated that your firm reviewed training records and work instructions, and updated training records for all employees. However, your firm’s response did not include evidence of implementation of the corrective actions.
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including the external automated defibrillators, are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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.
Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps that 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 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. 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 Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case 445485 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at telephone +1 301-796-5587 or fax +1 301-847-8139.
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
Mr. Vinoid Ramnani
Chief Managing Director
Opto Circuits (India) Ltd.
Plot No. 83, First Floor