Drug factory · FDA FEI 3002408934

Island Kinetics, Inc. d.b.a. CoValence Laboratories

460 S. Benson Ln. Ste. #3, Chandler, AZ, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

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

Jan 23, 2026 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  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.
• 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.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  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.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine inspection and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.

Jan 6, 2020 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.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  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.
• Drug product sample 21 CFR 211.160(b)(3)
  Drug product samples are not representative of the entire batch.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established specifications and quality control criteria are not rejected.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  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.
• Written sanitation procedures not followed 21 CFR 211.56(b)
  Written procedures for sanitation are not followed.
• Written calibration / inspection records not kept 21 CFR 211.68(a)
  Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the sampling of components.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
  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.
• Retest of approved components/containers/closures 21 CFR 211.87
  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.

Sep 2, 2016 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.
• Identification of containers, lines, equipment 21 CFR 211.105(a)
  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.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of standards, test procedures and laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
• Drug product sample 21 CFR 211.160(b)(3)
  Drug product samples are not representative of the entire batch.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include meaningful and specific test methods.
• Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
  Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures.
• 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.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to review production records to assure that no errors have occurred.
• Protective Apparel Not Worn 21 CFR 211.28(a)
  Protective apparel is not worn as necessary to protect drug products from contamination.
• Written procedures not established/followed 21 CFR 211.67(b)
  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.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the cleaning and sanitizing of equipment.
• Written calibration / inspection records not kept 21 CFR 211.68(a)
  Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
• Components withheld from use pending release 21 CFR 211.84(a)
  Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
• Top/Middle/Bottom container sampling 21 CFR 211.84(c)(4)
  Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container.
• 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.

Registered with FDA for: label; manufacture.