Drug factory · FDA FEI 1930436

MPP Pharma LLC

1800 N Topping Avenue, Kansas City, MO, 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.

Apr 2, 2026 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish 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.
• Adequate number of batches on stability 21 CFR 211.166(b)
  An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
• 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.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not established.
• 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.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• 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.
• Representative Samples Criteria 21 CFR 211.84(b)
  The number of containers to be sampled is not based upon appropriate criteria.
• Systems in place to comply with verification requirements FDCA 582(b)(4)
  Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
• Establishing Enhanced Systems FDCA 582(g)(1)
  Your firm failed to establish secure, interoperable, electronic systems and processes necessary to process requests for verification at the package level, respond with the relevant transaction information (at the package level) and transaction statement for a product upon request by FDA or other appropriate Federal or State official in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product and associate a saleable return product with its applicable transaction information and transaction statement to allow a trading partner to accept the returned product.

Sep 20, 2024 inspection

• Failure to develop written procedures 21 CFR 314.80(b)
  Written procedures have not been developed for the of post marketing adverse drug experiences.
• Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
  Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.

Apr 21, 2021 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
• 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.

Nov 5, 2010 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.
• Actual vs. theoretical yields not determined 21 CFR 211.103
  Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, and holding of the drug product.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and 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.
• Deviations of production time limits 21 CFR 211.111
  Deviations from production time limits are not justified and are not documented.
• Reprocessing procedures not written or followed 21 CFR 211.115(a)
  Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.
• Acceptance criteria for sampling & testing 21 CFR 211.165(d)
  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.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
• Adequate number of batches on stability 21 CFR 211.166(b)
  An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
• 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 and other drug products that may have been associated with the specific failure or discrepancy.
• Lack of quality control unit 21 CFR 211.22(a)
  There is no quality control unit.
• 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 , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training and experience required to perform their assigned functions.
• Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
  Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Registered with FDA for: analysis; label; manufacture; pack.