Drug factory · FDA FEI 3000280957
Delpharm Boucherville Canada Inc.
145 Rue Jules-Leger Street, Boucherville, Canada
Problems found, fixed voluntarily at FDA's last inspection, Jan 26, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Phenylephrine | Makes it, tests it, packages it, labels it and sterilizes it | Sandoz Inc. | 0781-9226, 0781-9227, 0781-9228 |
| Rocuronium | Makes it, tests it, packages it, labels it and sterilizes it | Sandoz Inc. | 0781-3220 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 26, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Feb 11, 2020 | No problems found | Drug Quality Assurance | — |
| Jun 12, 2018 | No problems found | Drug Quality Assurance | — |
| Aug 9, 2016 | No problems found | Drug Quality Assurance | — |
| Oct 22, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Aug 4, 2011 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jul 15, 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.
Jan 26, 2024 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The control systems necessary to prevent contamination or mix-ups are deficient. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Oct 22, 2013 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 and written. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. - Theoretical yield statement including percentages 21 CFR 211.186(b)(7)
Master production and control records lack a statement of theoretical yield including the maximum and minimum percentages of theoretical yield beyond which investigation is required. - 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 and other drug products that may have been associated with the specific failure or discrepancy. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection and checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance. - Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
Registered with FDA for: analysis; label; manufacture; pack; repack; sterilize.