FDA establishment 1000222037, Miami, Florida, United States. Part of Noven Pharmaceuticals's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 211.68(b). Backup file not maintained Failure to maintain a backup file of data entered into the computer or related system.
21 CFR 211.68(b). input/output verification Input to and output from records or data are not checked for accuracy.
21 CFR 211.194(a)(8). Second person sign off Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness.
21 CFR 211.84(d)(1). Identity Testing of Each Component 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.
Voluntary Action Indicated (VAI)
Feb 13, 2026
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Nov 17, 2021
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jan 26, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jul 10, 2015
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Sep 24, 2012
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jun 4, 2012
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
May 6, 2010
Drugs · Drug Quality AssuranceDrugs · Bioresearch Monitoring
6 cited references
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 211.100(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 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the handling, sampling, and testing of components.
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 211.68(a). Calibration/Inspection/Checking not done Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established and followed that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch.
Voluntary Action Indicated (VAI)
Feb 6, 2009
Drugs · Drug Quality AssuranceDrugs · Bioresearch Monitoring
9 cited references
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
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 211.165(d). Acceptance criteria for sampling & testing Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
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 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review 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 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing.
21 CFR 211.160(b)(1). Samples (various types) representative, identified properly Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of components are not representative.
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Miami, Florida, United States. Part of