Drug factory · FDA FEI 2650090
Baxter Healthcare Corporation
ROUTE #3 KM 144.2, Guayama, PR, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 26, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2010: 4 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Desflurane | Makes it, makes the active ingredient, tests it, packages it and labels it | Baxter Healthcare Corporation | 10019-641, 10019-644, 10019-646 |
| Isoflurane | Makes it, makes the active ingredient, tests it, packages it and labels it | Baxter Healthcare Corporation | 10019-360 |
| Sevoflurane | Makes it, makes the active ingredient, tests it, packages it and labels it | Baxter Healthcare Corporation | 10019-651, 10019-653, 10019-655 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 26, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 24, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 13, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 6, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 4, 2013 | No problems found | Drug Quality Assurance | — |
| May 18, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 30, 2011 | No problems found | Drug Quality Assurance | — |
| Sep 30, 2010 | Serious problems, FDA action | 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.
Mar 26, 2025 inspection
- 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.
Oct 24, 2018 inspection
- In-process and laboratory control results 21 CFR 211.188(b)(5)
Batch production and control records do not include in-process results for each batch of drug product produced. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
Feb 6, 2015 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.