Drug factory · FDA FEI 3000198340
Confab Laboratories Inc.
4355 Sir Wilfrid Laurier Boulevard, Saint Hubert, Canada
No problems found at FDA's last inspection, Feb 3, 2023.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2009: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Barium | Makes it, tests it, packages it and labels it | E-Z-Em, Inc. | 10361-778 |
| Mesalamine | Makes it, tests it, packages it and labels it | Nordic Pharma, Inc. | 69918-560 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 3, 2023 | No problems found | Drug Quality Assurance | — |
| Dec 1, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Oct 30, 2015 | No problems found | Drug Quality Assurance | — |
| Oct 24, 2014 | No problems found | Drug Quality Assurance | — |
| Jun 7, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 29, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 8, 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.
Dec 1, 2017 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - 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. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Rejected Material Area 21 CFR 211.42(c)(2)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected drug product containers before disposition. - 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.
Jun 7, 2013 inspection
- Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
Sep 29, 2011 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. - Test method modification records do not include 21 CFR 211.194(b)
Records maintained of any modification of an established method employed in testing do not include the reason for the modification and the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method.
Registered with FDA for: analysis; label; manufacture; pack.