Drug factory · FDA FEI 1420913

Morton Grove Pharmaceuticals, Inc.

Morton Grove, Illinois, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

Serious problems, FDA action at FDA's last inspection, Feb 5, 2016.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

6 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Acetic Acid	Makes it, tests it, packages it and labels it	Morton Grove Pharmaceuticals, Inc.	60432-741
Codeine and Promethazine	Makes it, tests it, packages it and labels it	Morton Grove Pharmaceuticals, Inc.	60432-606
Fluticasone	Makes it, tests it and packages it	Morton Grove Pharmaceuticals, Inc.	60432-264
Hydroxyzine	Makes it, tests it, packages it and labels it	Morton Grove Pharmaceuticals, Inc.	60432-150
Levetiracetam	Makes it, tests it, packages it and labels it	Morton Grove Pharmaceuticals, Inc.	60432-831
Megestrol	Makes it, tests it and packages it	Morton Grove Pharmaceuticals, Inc.	60432-126

Ended	Result	Program	Problems noted
Feb 5, 2016	Serious problems, FDA action	Drug Quality Assurance	—
Mar 26, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 12, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	4
Mar 24, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	3
Sep 17, 2009	No problems found	Bioresearch Monitoring	—
Mar 17, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	2

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

Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance.
Investigations of discrepancies, failures 21 CFR 211.192
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.
Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

Valid stability test methods 21 CFR 211.166(a)(3)
The written stability program for drug products does not include meaningful test methods.
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.
Identity Testing of Each Component 21 CFR 211.84(d)(1)
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.

Test method modification records do not include 21 CFR 211.194(b)
Records maintained of any modification of an established method employed in testing do not include the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method.
Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.