Drug factory · FDA FEI 3006218434
Tolmar, Inc.
701 Centre Avenue, Fort Collins, CO, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 23, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
12 drug inspections on record since 2009: 0 with no problems, 12 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Metronidazole | Makes it | Omp, Inc. | 62032-507 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 23, 2024 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Jan 31, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 28, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 6, 2018 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Dec 6, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 20, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 16, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 31, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 7, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 20 |
| Sep 7, 2012 | Problems found, fixed voluntarily | Bioresearch Monitoring | 20 |
| Jun 30, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 11, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 23, 2024 inspection
- Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences. - Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
Jan 31, 2023 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Jan 28, 2020 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Dec 6, 2017 inspection
- Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. - 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.
Registered with FDA for: analysis; label; manufacture; pack.