Recently, the State Medical Products Administration organized a flight inspection of Zhaoqing Dicai Daily Chemical Technology Co., Ltd. After inspection, it was found that the enterprise seriously violated the relevant provisions of the “Cosmetics Production License Work Specification”, and the quality management system mainly had the following defects:
1. Personnel management
(1) The quality person in charge of the enterprise has insufficient ability to perform his duties, and is not familiar with the basic contents of laws and regulations such as the “Cosmetics Production License Work Specification” and “Cosmetics Safety and Technical Specification” (2015 edition).
(2) The enterprise has not confirmed the effect of employee training.
(3) Water dispensers and drinking bottled water are placed in the second packaging room of the production workshop.
2. Quality management
(1) The enterprise has not established a systematic document management system and implemented it, such as the quality management system, catalog, record form and other documents are not controlled.
(2) The batch production record of the product is incomplete, such as Di Cai dyeing hair baking oil (natural black 2.0) (production date: 20190911) without weighing record and release record.
(3) The enterprise fails to inspect the products in accordance with the corresponding inspection standards. The operator expressed on the spot that the temperature of the product for cold resistance test did not meet the requirements of the identified foreign document (number: QB-T 1975-2013).
(4) The original test records are incomplete, and the pH value test does not record the test methods, judgment standards and instruments and equipment used in the inspection in accordance with the regulations.
(5) Two bottles of unmarked liquid were found on site stored in the refrigerator freezer of the inspection room, which did not meet the storage requirements of the inspection reagents.
(6) The enterprise has not implemented the finished product release system, and the finished product release slip cannot be provided on site.
(7) The enterprise cannot provide the 2017 internal audit report on site. The 2018 internal audit report did not meet the requirements of the company’s internal system document “Internal Inspection System” (document number: DC-QW-09), and did not analyze the causes of internal audit non-conformities and take necessary corrective and preventive measures.
3. Plant and facilities
(1) There are cracks in the wall of the workshop 2 production room, and the outlet of the air conditioning sewer pipe in the static room is located in the production room.
(2) Some materials in the cool warehouse are not placed off the wall. A large amount of Di Cai Baking Oil Moisturizing Shampoo (production date: 20190910) is stored in the channel between workshop 1 and finished product warehouse 2, without insect and dust prevention facilities.
4. Equipment management
(1) The pressure gauge of the emulsifier in workshop 2 (equipment number: ZD-CJS-PL-YH02) has no calibration mark and calibration report.
(2) The enterprise cannot provide the external inspection report of the production water of workshop 2 on site.
5. Materials and products
(1) The content of the product label is inconsistent with the approval documents, such as Di Cai dyeing hair baking oil (natural black 2.0) (approval number: national makeup special character G20150549; production date: 20190911) The information of the entrusting party and the entrusted party indicated on the label does not match the information of the manufacturer registered in the approval document. Di Cai Essential Oil Anti-Dry Hydrating Anti-dandruff Shampoo (Batch Number: 019081910205; Production date: 20190819) The ingredients identified by the label are inconsistent with the ingredients registered in the filing certificate.
(2) The enterprise fails to retain samples of the products in accordance with regulations. A large number of samples of semi-finished products and finished products from 2017 to 2019 were placed in the corridor area on the second floor of the office building without sample labels. The number of retained samples does not meet the product quality inspection needs by 2 times.
6. Production management
The production process is not strictly implemented and controlled in accordance with the production process regulations. On-site spot check of the product Di Cai dyeing hair baking oil natural black (approval number: national makeup special character G20101217; Production date: 20190911) The raw material used in the batch production record is isoascorbic acid, which is inconsistent with the raw material of the product approval formula sodium ascorbate.
Zhaoqing Dicai Daily Chemical Technology Co., Ltd. has confirmed the defects of the above quality management system. The above-mentioned behavior of the enterprise seriously violated the relevant provisions of the “Cosmetics Production License Work Specification”. The State Medical Products Administration has asked the Guangdong Provincial Drug Administration to order the company to suspend the production and sales of all cosmetics, and seriously investigate and deal with the suspected illegal production of the enterprise according to law. After the enterprise has completed comprehensive rectification and passed the follow-up and re-inspection by the Guangdong Provincial Drug Administration, production and sales can be resumed.
Notice is hereby given.