Drug factory · FDA FEI 3001677091

Medefil, LLC

250 Windy Point Drive, Glendale Heights, IL, 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.

Jun 17, 2016 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile 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.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of components and drug product containers.
• Containers & Closures Clean, Sterilized, Pyrogen-free 21 CFR 211.94(c)
  Drug product containers were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
• Contamination control, Lack of or inadequate procedures 21 CFR 820.70(e)
  Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
• Lack of or inadequate receiving acceptance procedures 21 CFR 820.80(b)
  Procedures for acceptance of incoming product have not been adequately established.
• Nonconforming product, Lack of or inadequate procedures 21 CFR 820.90(a)
  Procedures have not been established to control product that does not conform to specified requirements.

Sep 15, 2014 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
• 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.
• Lack of or inadequate procedures 21 CFR 820.100(a)
  Procedures for corrective and preventive action have not been adequately established.
• Documentation 21 CFR 820.100(b)
  Corrective and preventive action activities and/or results have not been adequately documented.
• Quality audits - auditor independence 21 CFR 820.22
  Individuals who conduct quality audits have direct responsibility for the matters being audited.

Dec 20, 2012 inspection

• Lack of System for Event Evaluations 21 CFR 803.17(a)(1)
  The written MDR Procedure does not include an internal system which provides for the timely and effective identification and evaluation of events that may be subject to medical device reporting requirements.
• Documented evaluation 21 CFR 820.50(a)(1)
  The evaluation of potential suppliers, contractors, and consultants was not documented.

May 25, 2012 inspection

• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written standards, test procedures, and laboratory mechanisms are not recorded and justified.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components, drug product containers, closures, and drug products conform to appropriate standards of identity, strength, quality and purity.
• Lack of System for Event Evaluations 21 CFR 803.17(a)(1)
  The written MDR Procedure does not include an internal system which provides for the timely and effective identification of events that may be subject to medical device reporting requirements.
• Lack of or inadequate receiving acceptance procedures 21 CFR 820.80(b)
  Procedures for acceptance of incoming product have not been adequately established.
• Nonconforming product control 21 CFR 820.90(a)
  Products that do not conform to specifications are not adequately controlled.

Registered with FDA for: analysis; label; manufacture; pack; relabel; repack; sterilize.