FDA establishment 2432435, Melville, New York, United States. Part of Fougera Pharmaceuticals Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
21 CFR 211.94(a). Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are reactive, additive and absorptive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug product containers conform to appropriate standards of identity, strength, quality and purity.
Voluntary Action Indicated (VAI)
May 29, 2018
Drugs · Drug Quality Assurance
1 cited reference
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.
Voluntary Action Indicated (VAI)
Nov 10, 2016
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Dec 23, 2014
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
Voluntary Action Indicated (VAI)
Oct 31, 2013
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Voluntary Action Indicated (VAI)
Nov 16, 2012
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Voluntary Action Indicated (VAI)
Jun 15, 2012
Drugs · Drug Quality AssuranceDrugs · Bioresearch Monitoring
None posted
Voluntary Action Indicated (VAI)
Feb 9, 2011
Drugs · Bioresearch MonitoringDrugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jan 12, 2010
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
16 cited references
21 CFR 211.194(a)(7). Signatures and dates--person who performs test Laboratory records do not include the initials or signature of the person who performs each test and the date(s) the tests were performed.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 314.81(b)(1)(ii). Failure to meet specifications 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.
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 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
21 CFR 211.186(b)(9). Complete instructions, procedures, specifications et. al. Master production and control records lack complete manufacturing and control instructions and special notations.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
21 CFR 211.160(a). Following/documenting laboratory controls Established standards and laboratory control mechanisms are not followed.
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 211.67(a). Cleaning / Sanitizing / Maintenance 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.
21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
21 CFR 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining expiration dates.
21 CFR 211.160(b)(4). Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
21 CFR 211.68(a). Written calibration / inspection records not kept Records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Voluntary Action Indicated (VAI)
Feb 6, 2009
Drugs · Drug Quality AssuranceDevices · Compliance: Devices
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
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