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Island Kinetics, Inc. d.b.a. CoValence Laboratories
FDA establishment 3002408934, Chandler, Arizona, United States. Part of Island Kinetics, Inc. d.b.a. CoValence Laboratories's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 6
Official action indicated: 1
Last inspection ended: Jan 23, 2026
Warning letters: 1
Recalls since 2016: 3
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine inspection and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
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.
Official Action Indicated (OAI)
Jan 6, 2020
Drugs · Drug Quality Assurance
13 cited references
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.
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch.
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established specifications and quality control criteria are not rejected.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations.
21 CFR 211.68(a). Written calibration / inspection records not kept Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
21 CFR 211.84(d)(2). Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
21 CFR 211.160(b)(3). Drug product sample Drug product samples are not representative of the entire batch.
21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the sampling of components.
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 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.87. Retest of approved components/containers/closures Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.
21 CFR 211.56(b). Written sanitation procedures not followed Written procedures for sanitation are not followed.
Voluntary Action Indicated (VAI)
Sep 2, 2016
Drugs · Drug Quality Assurance
16 cited references
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch.
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 211.160(a). Lab controls established, including changes The establishment of standards, test procedures and laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
21 CFR 211.105(a). Identification of containers, lines, equipment All compounding and storage containers and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents.
21 CFR 211.166(a)(3). Valid stability test methods The written stability program for drug products does not include meaningful and specific test methods.
21 CFR 211.84(c)(4). Top/Middle/Bottom container sampling Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container.
21 CFR 211.28(a). Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.
21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to review production records to assure that no errors have occurred.
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.
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 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.160(b)(3). Drug product sample Drug product samples are not representative of the entire batch.
21 CFR 211.68(a). Written calibration / inspection records not kept Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
21 CFR 211.186(b)(9). Complete instructions, procedures, specifications et. al. Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures.
21 CFR 211.84(a). Components withheld from use pending release Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
21 CFR 211.67(c). Cleaning/maintenance records not kept Records are not kept for the cleaning and sanitizing of equipment.
Voluntary Action Indicated (VAI)
May 16, 2012
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Apr 21, 2011
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jun 16, 2010
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Chandler, Arizona, United States. Part of