Drug factory · FDA FEI 3002807086
Bora Pharmaceutical Services Inc
7333 Mississauga Rd, Mississauga, Canada
Problems found, fixed voluntarily at FDA's last inspection, Jan 28, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2008: 6 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Albendazole | Makes it, tests it and packages it | Amneal Pharmaceuticals | 0115-1701, 64896-693 |
| Anastrozole | Makes it | Upsher-Smith Laboratories, Inc. | 24979-725 |
| Baclofen | Makes it, tests it and packages it | Slayback Pharma LLC | 71225-140 |
| Carvedilol | Makes it | Waylis Therapeutics LLC | 80725-383, 80725-385, 80725-387 +1 |
| Dasatinib | Makes it | Cycle Pharmaceuticals Ltd. | 70709-151, 70709-152, 70709-153 +3 |
| Lidocaine | Makes it, tests it, packages it and labels it | The J. Molner Company LLC | 83148-043 |
| Tapinarof | Makes it, tests it and packages it | Organon LLC | 81672-5051 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
| Nov 7, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 22, 2017 | No problems found | Drug Quality Assurance | — |
| Jul 24, 2015 | No problems found | Drug Quality Assurance | — |
| Jul 21, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 25, 2013 | No problems found | Drug Quality Assurance | — |
| Aug 15, 2011 | No problems found | Drug Quality Assurance | — |
| Jul 16, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 10, 2008 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 10, 2008 | 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 28, 2025 inspection
- Written procedures not followed 21 CFR 211.122(a)
Written procedures for the handling of packaging and labeling materials are not followed. - Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the prior to release. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Testing in same container - closure system 21 CFR 211.166(a)(4)
The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed. - Identification of persons involved, each significant step 21 CFR 211.188(b)(11)
Batch production and control records do not include the identification of the persons performing each significant step in the operation, for each batch of drug product produced. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Laboratory equipment calibration records 21 CFR 211.194(d)
Laboratory records do not include complete records of the periodic calibration of laboratory. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection and checking of electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; label; manufacture; pack.