Drug factory · FDA FEI 1450743

A-S Medication Solutions LLC

2401 Commerce Drive, Libertyville, 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.

Aug 12, 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.
• 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.

May 29, 2013 inspection

• 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.

Mar 2, 2012 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• Distinctive ID or code not recorded in batch record 21 CFR 211.105(b)
  The batch records do not record the distinctive identification number to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
• Destruction of obsolete labeling 21 CFR 211.122(e)
  Obsolete or outdated labels, labeling and packaging materials are not destroyed.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not established and followed.
• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment cleaning are not included in individual equipment logs.
• Maintenance of Complaint File 21 CFR 211.198(b)
  Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.
• Written record of complaint to include findings, follow-up 21 CFR 211.198(b)(2)
  Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.
• Reason for Not Conducting Complaint Investigation 21 CFR 211.198(b)(3)
  Complaint records are deficient in that they do not document the reason and the individual making the decision not to conduct a complaint investigation.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned 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 calibration of electronic equipment is not performed according to a written program designed to assure proper performance.

Oct 22, 2009 inspection

• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Lot or control number assigned 21 CFR 211.130(c)
  The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
• Quarantine - written procedures 21 CFR 211.142(a)
  Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program.
• 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.
• Reserve drug product sample quantity - all tests 21 CFR 211.170(b)
  The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product.
• Quality control unit review of records 21 CFR 211.192
  Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.

Registered with FDA for: relabel; repack.