Page 121 - 2021 Taiwan Food and Drug Administration Annual Report
P. 121

Table 10 Collaborative Inspection of Food, Drugs and Cosmetics in 2020

Inspection  Numbering       Project name                                    Results
    type               (Implementation time)

                                                Inspected: 22 companies

            1          The collaborative        I. GHP: 7 companies were required to make improvements within a
                       inspection project for      deadline and all of them passed the re-inspection.
                       egg products (July to
                       December)                II. Registration: 1 company was required to make improvements within
                                                   a deadline and it passed the re-inspection.

                                                III.Random inspection: 31 cases of liquid egg products, all complying

                                                with the regulations.

                                                Inspected: 111 companies

                                                I. GHP: 30 companies were not applicable, 18 companies were

                       Project joint inspection required to make improvements within a deadline and all of them

                       a c t i o n p l a n f o r passed the re-inspection.

            2          chemical raw material II. Registration: 27 companies were required to make improvements
                       industry project for the within a deadline and all of them passed the re-inspection.

 Food                  sale of food additives III. Labeling: 162 cases, of which 1 case did not meet the regulations.
 safety
                       (August to October) IV. Checked whether there were separately packaged unilateral food
Medical
devices                                         additives for distribution: 24 companies were not applicable and the

 Drugs                                          remaining 87 companies were in compliance with regulations.

                                                Inspected: 20 companies

                                                I. GHP: 4 companies were not applicable, 7 companies were required

                                                to make improvements within a deadline and all of them passed the

                       J o i n t i n s p e c t i o n re-inspection.

                       project plan for supply II. Registration: 4 companies were required to make improvements

            3          c h a i n o f d o m e s t i c within a deadline and all of them passed the re-inspection.
                       l o n g a n h o n e y III. Labeling: 27 cases, of which 5 cases did not meet the regulations.

                       products (November IV. Product liability insurance: 3 companies were not applicable and the

                       to December)             remaining 17 companies were in compliance with the regulations.

                                                V. Traceability: 1 company was not applicable, 4 companies were

                                                required to make improvements within a deadline and all of them

                                                passed the re-inspection.

                                                Inspected 55 medical device stores and online stores, and inspected

                                                42 cases of medical devices, of which 6 cases products were in

            1          Medical device           YLRODWLRQ  RI  WKH  UHOHYDQW  SURYLVLRQV  RI  WKH  3KDUPDFHXWLFDO $ႇDLUV $FW  
                       collaborative            7KH  YLRODWLRQV  LQFOXGHG  WKH  FRQWHQWV  RI  WKH  LQVWUXFWLRQ  OHDÀHW   SURGXFW 
                       inspection (August to    instructions, product use and maintenance manuals not compliant
                       October)
                                                with the original approvals, no medical device license, on-site product

                                                VSHFL¿FDWLRQV  QRW  PHHWLQJ  WKH  VSHFL¿FDWLRQV  FRQWDLQHG  LQ  WKH  RULJLQDO 

                                                catalogs. 1 company that sold medical devices did not apply for a

                                                pharmaceutical license.

                                                Audited 64 medical institutions, of which 8 clinics were involved in

            1          Joint drug inspection    violations of the provisions of the Pharmaceutical Affairs Act. The
                       program – Inspection     violations included that pharmacies did not have a pharmacist’s license
                       for illegal drugs (June  to sell wholesale drugs to clinics, and that the clinics did not have a
                       to August)               pharmacist’s license but imported and used the drug without obtaining
                                                a drug license, and other circumstances such as the display or storage

                                                of expired drugs or the use of expired drugs in clinics.

            2          Joint drug inspection    Audited 5 medical institutions and a total of 20 patients. Among them,
                       program – Inspection     4 medical institutions and a total of 15 patients’ medical records were
                       for project import       found not consistent with the original medical institution’s prescription
                       drugs for personal use   date or content.
                       (June to August)

Controlled  1          Inspection Project       230 companies were inspected, and 43 companies were found to be in
   drugs               for Controlled Drugs     violation of regulations. The violations were listed as top 3, in the form
                       (June to October)        of inaccurate records, failure to comply with the regulations of drug
                                                dispensing, and improper medical use.

                       Joint audit plan for

                       cosmetics claimed 36 companies were inspected, all of which met the requirements. 5

Cosmetics   1          to contain negative products were sampled and sent to the Institute of Nuclear Energy
                       ions, far-infrared rays, Research of the Atomic Energy Council of the Executive Yuan to test

                       germanium, titanium, the radiation content, and all of them passed the inspection.

                       etc. (July to October)

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