Drug factory · FDA FEI 1000115351

Elba, Inc.

1925 W. Maple Rd Ste B, Troy, MI, 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.

May 13, 2025 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  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.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Records reviewed annually 21 CFR 211.180(e)
  Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned at appropriate intervals to prevent 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 calibration of equipment is not performed according to a written program designed to assure proper performance.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Oct 5, 2017 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.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  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.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Written procedures not established/followed 21 CFR 211.67(b)
  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.

Mar 20, 2014 inspection

• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments is not done at suitable intervals in accordance with an established written program.
• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the prior to release.
• Sampling and testing plans not described 21 CFR 211.165(c)
  Sampling and testing plans for drug products are not described in written procedures which include the method of sampling.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established specifications are not rejected.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include reliable, meaningful, and specific test methods.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of 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.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• Suitability of testing methods verified 21 CFR 211.194(a)(2)
  The suitability of all testing methods is not verified under actual conditions of use.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• 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.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
• Contamination with filth FDCA 601(b)
  Your cosmetic consists in whole or in part of any filthy, putrid, or decomposed substance.

Sep 27, 2012 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.
• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
• Microbiological testing 21 CFR 211.165(b)
  Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
• 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 test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Electronic records are used, but they do not meet audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Suitability of testing methods verified 21 CFR 211.194(a)(2)
  The suitability of all testing methods is not verified under actual conditions of use.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  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.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Registered with FDA for: analysis; manufacture; pack.