Drug factory · FDA FEI 3004021263

Aurobindo Pharma Limited

Unit-VI, Sy. No.329/39 & 329/47, Chitkul Village, Patancheru Mandal, Sanga Reddy District, Sangareddy, India

Problems found, fixed voluntarily at FDA's last inspection, Sep 29, 2023.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

5 drug inspections on record since 2010: 1 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Cefadroxil	Makes it and tests it	Aurobindo Pharma Limited, Northstar Rx LLC., Rising Pharma Holdings, Inc.	65862-083, 65862-084, 65862-085 +6
Cefdinir	Makes it and tests it	Aurobindo Pharma Limited, BluePoint Laboratories., Rising Pharma Holdings, Inc.	65862-177, 65862-218, 65862-219 +2
Cefixime	Makes it and tests it	Aurobindo Pharma Limited	59651-647, 65862-751, 65862-752
Cefpodoxime	Makes it and tests it	Aurobindo Pharma Limited, Cronus Pharma LLC, Northstar Rx LLC., Rising Pharma Holdings, Inc.	65862-095, 65862-096, 65862-140 +9
Cefprozil	Makes it and tests it	Aurobindo Pharma Limited, Northstar Rx LLC., Rising Pharma Holdings, Inc.	65862-068, 65862-069, 65862-099 +9
Cefuroxime	Makes it and tests it	Aurobindo Pharma Limited, Northstar Rx LLC., Rising Pharma Holdings, Inc.	65862-698, 65862-699, 65862-700 +4
Cephalexin	Makes it and tests it	Aurobindo Pharma Limited, Cronus Pharma LLC	59651-322, 59651-323, 59651-728 +6

FDA inspection history

Ended	Result	Program	Problems noted
Sep 29, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	1
Sep 1, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 9, 2014	No problems found	Drug Quality Assurance	—
Sep 21, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	7
Dec 22, 2010	Serious problems, FDA action	Drug Quality Assurance	—

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Sep 29, 2023 inspection

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Sep 21, 2012 inspection

Absence of Written Procedures 21 CFR 211.100(a)
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.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Microbiological testing 21 CFR 211.165(b)
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Approve or reject components, products 21 CFR 211.22(a)
The quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, packaging material, and labeling.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Registered with FDA for: analysis; manufacture.