Drug factory · FDA FEI 1937310

Nomax, INC

9735 Green Park Industrial Drive, Saint Louis, MO, 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.

Oct 27, 2016 inspection

• Documentation 21 CFR 820.100(b)
  Corrective and preventive action activities and/or results have not been adequately documented.
• DHR - not or inadequately maintained 21 CFR 820.184
  A device history record has not been maintained.
• 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.
• Management review dates 21 CFR 820.20(c)
  The results and/or dates of management reviews are not documented.
• Evaluation and Selection, Suppliers, Contractors, etc. 21 CFR 820.50(a)(1)
  Potential suppliers were not evaluated based on their ability to meet specified requirements.
• Documentation 21 CFR 820.80(e)
  Acceptance activities were not adequately documented.
• Nonconforming product control 21 CFR 820.90(a)
  Products that do not conform to specifications are not adequately controlled.

Jan 31, 2012 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  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.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not documented at the time of performance.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  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.
• Establishment of calibration procedures 21 CFR 211.160(b)(4)
  Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
• 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.
• Drug product reserve containers 21 CFR 211.170(b)
  Drug product reserve samples are not stored in an immediate container-closure system that has essentially the same characteristics as the marketed product.
• Identity of major equipment and lines used 21 CFR 211.188(b)(2)
  Batch production and control records do not include the identity of individual major equipment used for each batch of drug product produced.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  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.
• Documentation 21 CFR 820.100(b)
  Corrective and preventive action activities and/or results have not been adequately documented.

Mar 25, 2011 inspection

• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.

Registered with FDA for: manufacture.