Drug factory · FDA FEI 3000999767
Labomar Canada Inc
50 boul Hymus, Pointe-Claire, Canada
No problems found at FDA's last inspection, Aug 9, 2024.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Naproxen | Makes it | Acella Pharmaceuticals, LLC | 42192-619 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 9, 2024 | No problems found | Drug Quality Assurance | — |
| Nov 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 5, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 2, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 13, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 15, 2016 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
Master production and control records lack sampling and testing procedures. - Quarantine of Rejected Components et. al. 21 CFR 211.89
Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
Aug 13, 2009 inspection
- Unlabeled filled containers controls 21 CFR 211.130(b)
Filled drug product containers which are set aside and held in an unlabeled condition are not identified and handled to preclude mislabeling of individual containers, lots or portions of lots. - Specific information required in individual logs 21 CFR 211.182
Individual equipment logs do not show time, date, product, and lot number of each batch processed. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include instructions for protection of clean equipment from contamination prior to use. - Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the handling and sampling of components.
Registered with FDA for: label; manufacture; pack.