Drug factory · FDA FEI 3003579953
GE Healthcare Ireland Limited
IDA Business Park, Carrigtohill, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Nov 5, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2014: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gadodiamide | Makes it, packages it and labels it | GE Healthcare Inc. | 0407-0690 |
| Iodixanol | Makes it | GE Healthcare Inc. | 0407-2222, 0407-2223 |
| Iohexol | Makes it | GE Healthcare Inc. | 0407-1401, 0407-1411, 0407-1412 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 5, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 16, 2018 | No problems found | Drug Quality Assurance | — |
| Jun 28, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 15, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 15, 2014 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 and documented at the time of performance. - 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. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing, packing, and holding of a drug product lack the training required to perform their assigned functions. - Written sanitation procedures not followed 21 CFR 211.56(b)
Written procedures for sanitation are not followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: label; manufacture; pack.