Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
21 CFR 211.180(c). Records not made readily available to FDA Records associated with drug product production and distribution and within the retention period for such records, were not made readily available for authorized inspection.
21 CFR 211.52. Washing and toilet facilities are deficient Washing and toilet facilities lack soap or detergent and air driers or single-service towels.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.
21 CFR 211.101(b). Measured components for manufacturing Components for drug product manufacturing are not weighed and subdivided as appropriate.
21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
21 CFR 211.28(a). Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.
21 CFR 211.44. Adequate lighting not provided Adequate lighting is not provided in all areas.
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 strength, quality, and purity of drug products.
21 CFR 211.186(a). Written procedures followed Procedures for the preparation of master production and control records are not described in a written procedure.
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. 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 and warning letters
Nanchang, China. Every inspection FDA has posted for the site, with its outcome and cited regulations.