Drug factory · FDA FEI 3005202761
Norgine Limited
7 Tir-y-berth Industrial Estate New Road, Tir-y-berth, Hengoed, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Jun 20, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate | Makes it | Oceanside Pharmaceuticals., Salix Pharmaceuticals, Inc. | 68682-201, 65649-201, 65649-400 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 20, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Aug 16, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 20, 2025 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications 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. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Component identification test 21 CFR 211.84(d)(2)
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
Aug 16, 2019 inspection
- Acceptance of drug products 21 CFR 211.160(b)(3)
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Registered with FDA for: analysis; label; manufacture; pack.