Drug factory · FDA FEI 3005689226
Pharmpur GmbH
Messerschmittring 33, Königsbrunn, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jun 18, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2014: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 18, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 7, 2016 | No problems found | Drug Quality Assurance | — |
| Jul 15, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 15, 2014 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch. - 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 and written. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Registered with FDA for: manufacture.