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Guangdong FDA Implements Supervision and Inspection Plan for Cosmetic Manufacturers and Distributors

  •   11 May 2018
  •    Hedy He
  •  359
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    Takehome:

    The Guangdong FDA is implementing a comprehensive supervision and inspection plan for cosmetic manufacturers and distributors in the province.

     In order to strengthen cosmetics post-market surveillance and guarantee the quality and safety of cosmetics, the Guangdong FDA is implementing a comprehensive supervision and inspection plan for cosmetic manufacturers and distributors in the province.

    (1)Routine Inspections

    According to the risk of manufacturing and distribution in the “List of Cosmetics Risks and List of Responsibilities for Risk in Guangdong Province” (see the annex list), the Guangdong FDA shall fully implement direct supervision and routine inspections of D-level risk cosmetics manufacturers and distributors. Routine inspection contents are as follows:

     Manufacturers:

    • Cosmetics registration and filing;
    •  Whether the used ingredient is consistent with the ingredient for registration and filing;
    • Cosmetic labels;
    • The traceability of the cosmetics quality, etc.

    Distributors:

    The focus of routine inspections of distributors is on the implementation of quality and safety management responsibilities of the wholesale market promoters, which mainly include:

    •  Review the legitimacy of cosmetic distributors in the wholesale market;
    • Establish a review system for the legitimacy of cosmetics on the market;
    • Inspect and record cosmetic distributors in the wholesale market regularly;
    • Handle and record the illegal cosmetics in accordance with the regulations;
    • Establish the rules and regulations for cosmetic distributors’ management and reporting of emergencies, etc.

    (2)Unannounced Inspections

    The Guangdong FDA will conduct unannounced inspections on 100 enterprises which: were previously found to have unqualified products during sampling tests, were notified by the regulatory authorities, subject of a complaint/report, problems found during risk monitoring process. The major targets of the inspection are on freckle eliminating, sunscreen, hair dye, acne and mask products. Unannounced inspection contents are as follows:

     Manufacturers:

    • Illegal production, illegal addition and illegal product labeling;
    • Whether the manufacturing process meets the requirements of the “Key points for Inspection of Cosmetics Production Licensing” ;
    • Evaluate the traceability of the cosmetics quality from ingredients purchase records, product records, inspection and sales records, etc.

     Distributors:

    The focus of inspections on distributors is the legitimacy and traceability of cosmetics, which mainly include:

    • Cosmetics production licenses and approval certificates (filing certificates) ;
    • Whether cosmetic labels are consistent with approval certificates;
    • Illegal advertising;
    • Whether to fulfill the request for invoices;
    • The responsibility of the ledger management, etc.

     The routine inspections will be carried out in a grid supervision mode, which consists of provincial, municipal, county (district) supervisors and technical staff. The unannounced inspections are mainly based on double randomization. Enterprises are randomly selected from the list of supervised enterprises and inspectors are randomly selected from the list of inspectors.

     Problems found in routine and unannounced inspections are, in principle, followed up by the prefecture-level regulatory authorities at the place where the enterprise is located and the results should be reported within one month. Sampling test shall be carried out on suspicious products found during the inspection.

    Annex list 1: Pre-judgment of Manufacturers Behavioral Risk in 2018 

    No.

    Name

    Description

    Event

    Degree

    Measure

    SC-01

    Enterprise Access

    Ultra-range production

    Product over-range varieties

    significant risk

    Key inspection

    SC-02

    Product Access

    Unregistered;

    Illegal production

    Unregistered;

    Illegal production

    Key risk

    special rectification

    SC-03

    Ingredient Usage

    Use prohibited and restricted ingredients

     

    Detection of prohibited ingredients or

    restricted ingredients excess

     

    Key risk

    special rectification

    SC-04

    Manufacturing Process

    Microbial contamination;

    No production records

    Microbial excess;

    Product quality is not traceable

    Significant risk

    Key Inspection

    SC-05

    Product Inspection

    Untested products

    Untested products

    General risk

    Random Inspection

    SC-06

    Labels

    Illegal product labeling

    Illegal product labeling

    Significant risk

    Key Inspection

    SC-07

    Product Sales

    Product quality is not traceable

    No sales records

    Significant risk

    Key Inspection

    SC-08

    Quality Traceability

    Adverse events

    Conceal adverse events

    General risk

    Random Inspection

    SC-09

    Sub-contract Production

    Illegal sub-contract production

    Unregistered products

    Significant risk

    Key Inspection

    Annex List 2: Pre-judgment of Distributors Behavioral Risk in 2018

    No.

    Name

    Description

    Event

    Degree

    Measure

    JY-01

    Enterprise Access

    No business license

    unlicensed business activities

    General risk

    Random Inspection

    JY-02

    Product Purchase

    Unregistered products;

    Product quality is not traceable

    No receipt of invoices and vouchers

    Key risk

    Special rectification

    JY-03

    Product Storage

    Unqualified storage conditions

    Quality Problem

    General risk

    Random Inspection

    JY-04

    Product Sales

    Illegal business

    Expired products on sale;

    Wholesale without a ledger

    General risk

    Random Inspection

    JY-05

    Quality Traceability

    Conceal adverse event

    Severe adverse event

    General risk

    Random Inspection

    Annex List 3: Pre-judgment of Illegal Behavioral Risk in 2018

    No.

    Name

    Description

    Event

    Degree

    Measure

    FF-01

    Illegal production

    Product without license

    Underground dens

    Key risk

    special rectification

    FF-02

    Illegal addition

    Use prohibited ingredients;

    restricted ingredients excess

    Detection of prohibited ingredients or

    restricted ingredients excess

    Key risk

    special rectification

    FF-03

    Illegal operation

    Illegal product sales

    Illegal product sales

    Key risk

    special rectification

    FF-04

    Illegal product labeling

    Illegal product labeling

    Illegal product labeling

    Key risk

    special rectification

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