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
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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
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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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