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FDA establishment 1450743, Libertyville, Illinois, United States. Part of A-S Medication Solutions's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 0
Last inspection ended: Aug 12, 2026
Warning letters: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.100(a). Absence of Written Procedures 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.
Voluntary Action Indicated (VAI)
Feb 16, 2023
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jun 5, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
May 29, 2013
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Voluntary Action Indicated (VAI)
Mar 2, 2012
Drugs · Drug Quality Assurance
11 cited references
21 CFR 211.198(b)(2). Written record of complaint to include findings, follow-up Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.
21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded and justified.
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not established and followed.
21 CFR 211.198(b). Maintenance of Complaint File Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.
21 CFR 211.180(e)(1). Review of representative number of batches 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.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment cleaning are not included in individual equipment logs.
21 CFR 211.122(e). Destruction of obsolete labeling Obsolete or outdated labels, labeling and packaging materials are not destroyed.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance 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.
21 CFR 211.198(b)(3). Reason for Not Conducting Complaint Investigation Complaint records are deficient in that they do not document the reason and the individual making the decision not to conduct a complaint investigation.
21 CFR 211.105(b). Distinctive ID or code not recorded in batch record 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.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
Voluntary Action Indicated (VAI)
Mar 24, 2010
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Oct 22, 2009
Drugs · Drug Quality Assurance
8 cited references
21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
21 CFR 211.192. Quality control unit review of records 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.
21 CFR 211.130(c). Lot or control number assigned 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.
21 CFR 211.160(b)(4). Calibration - at intervals, written program, remedial action The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program.
21 CFR 211.170(b). Reserve drug product sample quantity - all tests 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.
21 CFR 211.170(b). Annual visual exams of drug products 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.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.142(a). Quarantine - written procedures Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Libertyville, Illinois, United States. Part of