Drug factory · FDA FEI 3002948883
Aesica Pharmaceuticals GmbH
Galileistr. 6, Zwickau, Germany
Problems found, fixed voluntarily at FDA's last inspection, Aug 31, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carglumic Acid | Makes it | Orphan Europe SARL | 52276-312 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 31, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 30, 2019 | No problems found | Drug Quality Assurance | — |
| Dec 2, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 20, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 8, 2011 | 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.
Jun 20, 2014 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - 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.
Registered with FDA for: analysis; manufacture.