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FDA establishment 3012941723, Yuyao, China. Part of NingBo Huize Commodity's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 1
Official action indicated: 1
Last inspection ended: Mar 22, 2019
Warning letters: 1
Recalls since 2016: 1
Import refusals 2014 to 2023: 30, first Jul 5, 2018
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine inspection and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not documented at the time of performance.
21 CFR 211.22(c). Approve or reject procedures or specs The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.84(d)(2). Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
21 CFR 211.170(a). Active ingredient retained sample kept A sample which is representative of each lot in each shipment of each active ingredient is not retained.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Yuyao, China. Part of