Sugih Instrumendo Abadi, PT. 10/22/12
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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
OCT 22, 2012
Ade Tarya Hidayat
Sugih Instrumendo Abadi, PT.
J1. Tembokan Rt. 1/01, Ds. Cipeundeuy
Padalarang, Jawa Barat 40553, Indonesia
Dear Mr. Hidayat:
During an inspection of your firm located in Padalarang, Jawa Barat, Indonesia,on June 25, 2012, through June 28, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures aneroid sphygmomanometers (blood pressure cuffs). 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 July 18, 2012, 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:
- Failure to establish and maintain adequate 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: the first revision of the Design Control Procedure, Document #SIA-PO-27.01, Issue #1, Revision #0, was established on June 8, 2012. Your firm has yet to subject the aneroid sphygmomanometer, cleared under 510(k) of the Act, 21 U.S.C. § 360(k) (#K012444) on August 16, 2001, through the design control process in order to ensure that specified design requirements are met.
The adequacy of your firm’s response cannot be determined at this time. The corrective actions have not yet been completed by your firm.
- Failure to establish and maintain adequate acceptance procedures to ensure that specified requirements for in-process product are met, as required by 21 CFR 820.80(c).
For example: on June 26, 2012, (b)(4) defective aneroid gauges were randomly selected for review from a rejected bin of (b)(4) in the gauge manufacturing area. The gauges are used in the manufacturing of the aneroid sphygmomanometer. A review of these gauges revealed that the entire lot of aneroid gauges were checked by Quality Control and approved for transfer to the warehouse. However, some gauges from the lot were found in the rejection bin waiting for rework. (b)(4) gauges were found to have gone through rework due to a calibration failure. They passed inspection and they were then found in the rejected bin again waiting for rework.
The adequacy of your firm’s response cannot be determined at this time. Your firm has not provided documentation to verify that the corrections have been implemented.
- Failure to establish and maintain procedures to adequately develop, conduct, control, and monitor production processes to ensure that a device conforms to its specification, as required by 21 CFR 820.70(a).
For example: on June 26, 2012, your firm was manufacturing the (b)(4) for the sphygmomanometer bag in the (b)(4) area. It was observed that the manufacturing process failed to ensure the (b)(4) requirements were met. In addition, this was not documented.
The adequacy of your firm’s response cannot be determined at this time. Your firm’s response did not provide documentation to demonstrate that the (b)(4) manufacturing process is bring performed according to your firm’s manufacturing procedures.
- Failure to establish and maintain adequate procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184.
For example: your firm has yet to establish a DHR procedure. In addition, (b)(4) DHRs from the years 2011 and 2012, pertaining to the aneroid sphygmomanometer, were selected for review during the inspection. (b)(4) of the DHRs included or referred to the location of the primary identification label and labeling used for each production unit.
The adequacy of your firm’s response cannot be determined at this time. Your firm has not provided documentation to demonstrate that corrective actions have been implemented.
- Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of Part 820, as required by 21 CFR 820.20(c).
For example: Management Review Procedure, Document #SIA-PO-01.01, Issue #2, Revision #1, requires management reviews to be conducted (b)(4). However, (b)(4). This is evident for the years 2010 through 2012.
The adequacy of your firm’s response cannot be determined at this time. The actions have not yet been conducted and your firm has not provided documentation of the implementation.
A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.
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 (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. 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 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #559739 when replying. If you have any questions about the contents of this letter, please contact: Joshua Simms at (301) 796-5599.
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