Summary of Flight Inspection Results of Cosmetics Manufacturers (2017)

According to the requirements for supervision of cosmetics issued by China Food and Drug Administration, flight inspections were carried out for cosmetics manufactures holding Cosmetics Production Licenses by provincial/autonomous/municipal FDA, in order to urge enterprises to fully implement the responsibility of quality and safety, further standardize the production behavior of enterprises and check the potential safety dangers. The flight inspection was based on "Double random principles" which means "random selection of inspection objects or inspectors". The inspection mainly focused on the storage and use of raw materials, the verification and maintenance of production equipment, the compliance of the production workshop and process, and the compliance of cosmetics retention materials.

CIRS summarized the flight inspection results of all local administration in 2017 for reference of domestic cosmetics manufacturers so that enterprises can effectively carry out self-inspection.

From the summary table, it can be seen that in 2017, 16 provinces, municipalities and autonomous regions have carried out flight inspections, and more than 90 cosmetics manufacturers did not meet the requirements of cosmetics production license. According to the distribution area of cosmetics production enterprises, it can be analyzed that: the total number of unqualified cosmetics manufacturers in Fujian, Jiangsu, Jiangxi, Shanghai, Zhejiang and Shandong provinces is up to 52; As a concentrated area of cosmetics production enterprises, the local bureau in Guangdong province carried out two flight inspections in the end of March and November 2017, 4 enterprises were notified. The flight inspection is mainly based on the Inspection Points of Cosmetics Production License to check the production problems of production workshops, management and quality, as well as further to check the compliance, record and retention materials of recorded products.

Table1. Summarized results of flight inspection of each local bureau in 2017

Area

The month of inspection

 Number of unqualified cosmetics manufacturers

Summary of main problems

Heilongjiang Province

3

9

3

No cleaning facilities in the production workshop. 2. No cleaning facilities in the microbiology room, inadequate basic infrastructures. 3. Inadequate material storage facilities 4. Unreasonable installation of production equipment, And no certificate and periodic check plan. 5. Incomplete production records, and the product was not recorded. 6. Irregular setting of sample room, etc.

`Liaoning Province

9

2

1. Lack of files of responsible person for quality. Academic qualification did not meet the requirement.2. Lab management problems, lack of environmental control facilities in the microbiology room. Incomplete original record of inspection. 3. Part of production equipment without equipment status identification. 4. Equipment calibration and processing equipment were not properly calibrated. 5. No record to the purchase of raw material, non-compliance of management. 6. Batch production instructions were not standardized. 7. No input review, the production record was inconsistent with the product specification. 8. No batch number from sales record.

Beijing

9

11

4

1. Organizations and personnel responsibilities problems. 2. The equipment clean had no sterilization period. 3. Laboratory raw material was not properly kept, no original inspection records, no corresponding test equipment, did not indicate the test method. 4. Storage of materials and products was not regulated. 5. The condition control facility was not set up for the condition. 6. The actual operation was not consistent with the production process, the production process was unreasonable, and the material labeling in the production process was not standardized. 7. Failed to establish a perfect batch production record, failed to reasonably calculate the material balance, and failed to ensure that the products of different batches can be effectively identified.

Tianjin

12

2

1. Organizations and personnel responsibilities problems. 2. The quality control standard did not meet the requirement. 3. Raw material was not placed according to the precautions. 4. No inspection report and quality specification of relevant materials, and the management books were inconsistent. 5. The record product was not archived, the record information or the record product was inconsistent with the actual product.

Hebei province

11

6

1. No inspection report for nipin methyl ester

of raw materials. 2. Incomplete records of finished products. 3. Temperature and humidity records in storage are not timely registered. 4. The test report used the hygienic standard for cosmetics (2007 edition) instead of the 2015 edition; 5.Production records had a write up trace6. The skin care water was transported by pipeline, and it was recommended to improve the regulation of pipeline cleaning. 7. Production record and filling record information was not complete to reflect material balance. 8. The date of retention was not consistent with the date of the filling record. 9. The water shop pipe was unmarked. 10. Labeling card of raw materials in the storage was not complete, the outer packing had no specific production date (batch number) and the expiration date and related information of the raw material production enterprise.

Fujian Province

7

2

1. Production workshop cleaning and disinfection, safety environmental instructions and other problems, workshop environmental records are not perfect. 2. Equipment cleaning and disinfection problems. 3. Materials and products storage problems. Records were inaccurate. 4. Production management and laboratory management problems, no relevant records. 5. Product retention management problems. 6. Water treatment system monitoring and other issues.

Jiangsu Province

9

11

12

8.

1. The quality management system was not perfect, and there were irregularities. 2. Lack of related inspection system in production workshop. 3. Cleaning and disinfection of production equipment was not standard. 4. Production management problems. 5. The product is not filed as required. 6. The product risk assessment basis was not regulated, and the risk substance was not identified as required. 7. The product retention sample did not meet the requirements.

Jiangxi Province

10

6

1. The quality management department doesnot strictly perform the duties. 2. The inspectors have no certification. 3. The production environment was undisciplined. 4. Some of the products failed the test. 5. The production process records were not standardized and the sanitary conditions are substandard. 6. Raw material management was not accurate. 7.Production workshop operation was not standard and so on.

Shanghai

3

2

 

1. Quality management records were incomplete. 2. The production management system was not perfect. The production process operation content was not complete. 3. The recall system did not fulfill well. 4. Material acceptance and storage was not standardized, and records were not complete.

Zhejiang Province

10

11

12

10

1. The production process did not meet the requirements. 2. The cleaning of the workshop was not in accordance with the regulations, the regional setting was not reasonable, the facilities were not put in place, and the workshop environment was not tested regularly. 3. Improper use of production equipment. 4. The material storage was improper or exceeds the shelf life, the raw material quality standard was inconsistent with the actual production. 5. The raw material supplier was not in the qualified list, the quality management system was not perfect. 6. The production process records were incomplete and the archives are incomplete. 7. The cleaning standard was not strict in the actual production process. 8. The health certificate of the enterprise production staff had expired. 9. The production process water was not tested regularly. 10. The approved batch of products had expired and has not been extended. 11. No complete sales record. 12. No sample room. 13. The raw material label was incomplete. 14. Not fixed storage areas, waste was not handled in time.

Shandong Province

5

7

10

 

1. Production without licensed conditions. 2.Lack of production equipment of wax base unit. 3. Use of expired raw materials, improper raw material management, raw material storage was not stored according to the label, materials were in disorder, the information of the cargo card was not complete or not set up. 4. The production operation procedure was not perfect. 5. Production environment was not neat, placed no related equipment. 6. No personnel training program. 7. The environment in the sample room does not meet the requirements.

Guangdong Province

3

11

4

1. The semi-finished product storage was not Standard. 2. No pathogen detection in labs. 3. The enterprise had batch number coding principle but does not have relevant document regulation. 4. Quality management problems, the product production record was incomplete, the test report of water and the original record were not complete, and the product inspection activity was not carried out. 5. The production plant and facilities did not meet the requirements of the specification, and the production environment was not equipped with environmental monitoring facilities and pest control facilities. 6. Cleaning and disinfection of production equipment was not in conformity with the specification. 7. Raw material procurement information was incomplete, and the identification contents of raw materials, semi-finished products and finished products were incomplete. 8. The production process was not recorded completely. 9. The production wastes were not cleaned in time. 10. The retention sample did not meet the requirements. 11. Material management identifies inaccuracies, no semi-finished products management system, etc.

Henan Province

4

7

10

11

10

1. Check the company's original and auxiliary material warehouse, packaging material storage, finished product warehouse, production workshop, laboratory and company's room, collect enterprise cosmetics application materials, record data, production, inspection, sales account and other information. The problems were: Improper use of production workshop, incomplete production record, no environmental monitoring plan, and imperfect sanitation management system. 2. Improper material management. 3. The product formulation was inconsistent with the archival data. 4. The production management was not standardized, and the inspection and reserve management system was not strictly implemented. 5. The production manager was not familiar with the cosmetics production and production responsibilities. 6. Product not recorded. 7. The production workshop environment did not meet the specifications and so on.

Hubei Province

 

10

3

 

1. Improper production of waste products, production workshop environment chaos. 2. Production area set unreasonably, not effective isolation of cross contamination. 3. Production facilities and equipment were not identified. 4. The raw material identification did not meet the standard.

Hunan Province

12

1

 

 

1. Disinfection of production equipment was not standard. 2. The production records were incomplete, and the logo was not consistent with the actual input. 3. Use of raw materials was not standardized, and there was no identification of possible safety risk substances; 4. The claim on product packaging did not comply with relevant regulations.

Ningxia hui autonomous region.

11

2

1. Incomplete identification of raw materials and accessories. 2. Incomplete product production record. 3. Dirty production workshop environment, no state identification of production equipment, unreasonable distribution of production area. 4. Unreasonable raw material storage. 5. Unregulated sample retention. 6. Product filing packaging did not meet the requirements.

Shanxi Province

7

2

1. The production workshop settings were not standardized, the environmental monitoring was inconsistent with the records. 2. No long-term maintenance of the production equipment. 3. Existence of potential risk in raw materials storage. 4. Unreasonable supplier audit system and no material acceptance system. 5. Nonstandard name of raw materials. 6. Issues exist in the responsibility of responsible person. 7. No training plan. 8. Nonstandard product retention materials. 9. Nonstandard production management system, no relevant system, operators were not rigorous10No retention of some products.

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