Sanitation, Falsification Among Violations Cited by French Inspectors at Nandu Chemicals
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker.
During the inspection, French regulators found significant deficiencies that have been linked to the vast majority of inspected areas at Nandu’s site in Hubli, India.
Nandu manufactures more than 100 APIs at the site.
The issues included: falsification practices and inadequate control systems; risks of contamination; lack of basic hygiene practices for the packing area; poor standards for the management of retention samples and stability studies; failure of validation practices; in particular regarding analytical and cleaning validations; lack of cleaning methods; poor training practices; and deficient monitoring of the quality of purified water.
Based on the inspection findings, ANSM is recalling a number of products. Until the noncompliance report is resolved, ANSM says the site should not be named in any new marketing authorizations or drug compounding activities.
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