Drug factory · FDA FEI 3009997166
Glaropharm AG
Saendli 2, Mitlödi, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, May 31, 2023.
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 2018: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aminolevulinic Acid | Makes it, packages it and labels it | Biofrontera Inc. | 70621-101 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 31, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jun 15, 2018 | 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.
May 31, 2023 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not followed. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and 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. - Identity Testing of Each Component 21 CFR 211.84(d)(1)
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
Registered with FDA for: analysis; label; manufacture; pack.