Drug factory · FDA FEI 1416980

Baxter Healthcare Corporation

25212 W. Illinois Route 120, Round Lake, 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.

Apr 2, 2026 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded.
• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established specifications, standards, sampling plans, test procedures and laboratory control mechanisms are not followed and documented at the time of performance.
• Acceptance/Rejection Levels 21 CFR 211.165(d)
  The statistical quality control criteria fail to include appropriate acceptance levels and rejection levels.
• 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.
• 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.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The control systems necessary to prevent contamination or mix-ups are deficient.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• 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.

Jun 7, 2012 inspection

• Reactive/Additive/Absorptive Containers/Closures 21 CFR 211.94(a)
  Drug product containers or closures are additive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
• Individual Report of Malfunction 21 CFR 803.50(a)(2)
  An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
• Lack of or inadequate procedures 21 CFR 820.100(a)
  Procedures for corrective and preventive action have not been adequately established.
• Investigation of device failures 21 CFR 820.198(c)
  Complaints involving the possible failure of a device to meet any of its specifications were not evaluated where necessary.
• Design input - Lack of or inadequate procedures 21 CFR 820.30(c)
  Procedures for design input have not been adequately established.
• Design verification - documentation 21 CFR 820.30(f)
  The design verification results, including method(s), were not adequately documented in the design history file.
• Design verification - Lack of or inadequate procedures 21 CFR 820.30(f)
  Procedures for design verification have not been adequately established.
• Design verification - output does not meet input requirement 21 CFR 820.30(f)
  Design verification does not confirm that design output meets design input requirements.
• Design changes - Lack of or Inadequate Procedures 21 CFR 820.30(i)
  Procedures for design change have not been adequately established.

Mar 18, 2011 inspection

• Lack of Written MDR Procedures 21 CFR 803.17
  Written MDR procedures have not been implemented.
• Individual Report of Malfunction 21 CFR 803.50(a)(2)
  An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
• Lack of or inadequate procedures 21 CFR 820.100(a)
  Procedures for corrective and preventive action have not been adequately established.
• Investigation of device failures 21 CFR 820.198(c)
  Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated, and investigated where necessary.

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