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FDA establishment 3009864167, Sangareddy district, Hyderabad, India. Part of Gland Pharma's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 0
Last inspection ended: Aug 26, 2023
Warning letters: 0
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 820.70(g). Equipment Installation, Placement, Specified Requirements The appropriate design, construction, placement, and installation of manufacturing equipment have not been ensured.
21 CFR 820.186. QSR The quality system record has not been adequately maintained.
Voluntary Action Indicated (VAI)
Jun 27, 2023
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Nov 7, 2019
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that drug product containers, closures and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.84(b). Representative Samples Representative samples are not taken of each shipment of each lot of components for testing or examination.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
21 CFR 211.46(b). Equipment for Environmental Control Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Voluntary Action Indicated (VAI)
Feb 23, 2018
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.
21 CFR 211.110(b). In-process conformity - examination, sample testing Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
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
Sangareddy district, Hyderabad, India. Part of