- Pacific Hospital Supply Co., Ltd.
No. 19 Tzi-Chiang Road
Torng-Lo Industrial District
- Issuing Office:
- Center for Devices and Radiological Health
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10903 New Hampshire Avenue
Silver Spring, MD 20993
MAY 26, 2017
VIA UNITED PARCEL SERVICE
Senior Plant Manager
Pacific Hospital Supply Co., Ltd.
No. 19 Tzi-Chiang Road
Torng-Lo Industrial District
Dear Mr. Liao:
During an inspection of your firm located in Miaoli, Taiwan on February 20, 2017, through February 22, 2017,an investigatorfrom the United States Food and Drug Administration (FDA) determined that your firm manufactures disposable medical supplies including catheters, cannulae, tubing, and aspirators. 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 Mr. Jin Chung, President, dated March 3, 2017, 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 ensure that 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 procedures, as required by 21 CFR 820.75(a). For example, the (b)(4) process used to manufacture (b)(4), part number (b)(4), using (b)(4) number (b)(4) has not been validated. This was a 483 observation in the previous FDA inspection.
The adequacy of your firm’s response cannot be determined at this time. Your firm states that it is going to review previous (b)(4) process batch records to determine if the parameters are acceptable, and revalidate the (b)(4) processes specifically producing (b)(4) for exporting to the U.S. market. Your firm should review other processes to assure that they are adequately validated. Your firm should provide documentation, including verification effectiveness, demonstrating that the remediation has been completed. Your firm should also provide documentation that operators have been trained on the correct validated parameters.
2. Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 CFR 820.70(a). For example,
A. (b)(4) in your firm’s (b)(4) was operating at temperature and (b)(4) speed parameter settings that deviate from those defined by form MF4046.Q, containing parameter specification limits, for (b)(4), part number (b)(4) (See table below). You stated that the settings were chosen based on the results of first article inspection, which involves visual inspection and measurement of (b)(4). However, the observed operating parameters deviated from those specified on Form MF4046.Q as follows:
Specified operating parameters on Form MF4046.Q
Observed operating parameters
B. Your firm has not established process control procedures (e.g., the control of (b)(4) temperature) for the (b)(4) used to (b)(4).
This was a 483 observation in the previous FDA inspection.
The adequacy of your firm’s response cannot be determined at this time. Your firm states that it will review previous (b)(4) batch records to verify if the manufacturing parameters are acceptable, as well as install a thermometer for the (b)(4). Your firm also states it is revising its instructions by adding the actions regarding the follow-up investigation and/or revalidation process after a process deviation. Your firm states it is to record the results for the first two weeks after thermometer installation, and after evaluation, set the specification for the (b)(4) range in its current SOP. Your firm should provide documentation, including verification effectiveness, new SOPs, and related documents, demonstrating that the CAPA has been completed. Your firm should also provide documentation assuring that operators are trained on the correct validated parameters.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, procedures for verifying or validating the effectiveness of corrective actions have not been adequately established. CAPA #CP1050022 was initiated on “10/12/2016” due to failed (b)(4) tests in the suction catheter valve (b)(4). Your firm identified two root causes:
a. Insufficient (b)(4) used to (b)(4) connector and valve body components during the (b)(4), and
b. Inadequate mating between the connector and valve body components.
The identified respective corrective actions were to change the (b)(4) process to increase the amount (b)(4) used to (b)(4) the components, and to redesign the valve body component to better mate with the connector. The CAPA was closed on “1/19/2017.” However, at the time of this inspection, the component redesign was still in (b)(4) at the supplier. Additionally, revalidation of the process change was not completed until “2/7/2017.”
The adequacy of your firm’s response cannot be determined at this time. Your firm states that it is going to follow-up on the unfinished CAPA #CP1050022 to redesign the (b)(4) and product design changes. Your firm should provide documentation, including verification of effectiveness of the implementation of the design change, as well as revalidation of the (b)(4) process demonstrating that the CAPA has been completed. Your firm should also provide documentation assuring that operators are trained on the correct validated parameters.
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 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. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
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 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 522616 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Branch Chief, at firstname.lastname@example.org (e-mail) or 1-(240) 402-4020 (telephone).
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.
CAPT Sean M. Boyd, MPH, USPHS
Deputy Director for Regulatory Affairs
Office of Compliance
Center for Devices and Radiological Health
HPSRX ENTERPRISES INC
1640 Roanoke Blvd.
Salem, VA 24153