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FDA establishment 3004561553, Dadra, India. Part of Sun Pharmaceutical Industries's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 5
Official action indicated: 0
Last inspection ended: Mar 29, 2019
Warning letters: 1
Import refusals since 2024: 1
Import refusals 2014 to 2023: 3, first Sep 7, 2018
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 211.111. Establishment of time limitations Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to fully investigate errors that have occurred.
21 CFR 211.84(c)(4). Composite sample top/middle/bottom Sampling procedures are deficient regarding compositing for testing of samples collected from the top, middle, and bottom of the component container.
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 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education, training and experience required to perform their assigned functions.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the handling of components.
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 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
21 CFR 211.160(b)(3). Drug product sample Drug product samples are not representative of the entire batch.
Voluntary Action Indicated (VAI)
Apr 13, 2017
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jan 30, 2015
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
May 10, 2013
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jun 17, 2011
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
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
Dadra, India. Part of