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FDA establishment 1937310, Saint Louis, Missouri, United States. Part of Nomax Inc's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 7
Official action indicated: 1
Last inspection ended: Dec 2, 2022
Warning letters: 1
Recalls since 2016: 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 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 820.50(a)(1). Evaluation and Selection, Suppliers, Contractors, etc. Potential suppliers were not evaluated based on their ability to meet specified requirements.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been maintained.
21 CFR 820.80(e). Documentation Acceptance activities were not adequately documented.
21 CFR 820.20(c). Management review dates The results and/or dates of management reviews are not documented.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
Official Action Indicated (OAI)
Sep 17, 2014
Devices · Compliance: Devices
18 cited references
21 CFR 820.20(b). Lack of or inadequate organizational structure The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
21 CFR 820.50(a)(3). Acceptable supplier records, inadequate records Records of acceptable suppliers have not been established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been established to control product that does not conform to specified requirements.
21 CFR 820.22. Quality Audits - defined intervals Quality audits were not performed at defined intervals to determine whether the quality system activities and results comply with quality system procedures.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been established.
21 CFR 820.40. Lack of procedures, or not maintained Document control procedures have not been established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.120. Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been adequately established.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been established.
21 CFR 820.25(b). Training records Personnel training is not documented.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with 21 CFR 820.
21 CFR 820.80(c). Documentation In-process inspections, tests, or other verification activities and approvals were not documented.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures for device history records have not been established.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
21 CFR 820.186. QSR The quality system record has not been maintained
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been established.
Voluntary Action Indicated (VAI)
Jan 31, 2012
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
9 cited references
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which 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.
21 CFR 211.188(b)(2). Identity of major equipment and lines used Batch production and control records do not include the identity of individual major equipment used for each batch of drug product produced.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
21 CFR 211.160(b)(4). Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
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 211.100(b). SOPs not followed / documented Written production and process control procedures are not documented at the time of performance.
21 CFR 211.100(a). Absence of Written Procedures 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.
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.170(b). Drug product reserve containers Drug product reserve samples are not stored in an immediate container-closure system that has essentially the same characteristics as the marketed product.
Voluntary Action Indicated (VAI)
Mar 25, 2011
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
2 cited references
21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
Voluntary Action Indicated (VAI)
Jul 26, 2010
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Saint Louis, Missouri, United States. Part of