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FDA establishment 3006076314, Bengaluru, India. Part of Apotex Research Private Limited's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 8
Official action indicated: 2
Last inspection ended: Mar 15, 2024
Warning letters: 1
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 211.100(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 and fully followed.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Official Action Indicated (OAI)
Jul 12, 2013
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jun 22, 2012
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Apr 17, 2010
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
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. 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
Bengaluru, India. Part of