Drug factory · FDA FEI 3004967053
Apotek Produktion & Laboratorier AB
Prismavagen 2, Kungens Kurva, Sweden
No problems found at FDA's last inspection, Apr 28, 2022.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitisinone | Makes it | Swedish Orphan Biovitrum Ab (publ) | 66658-102, 66658-105, 66658-110 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 28, 2022 | No problems found | Drug Quality Assurance | — |
| Jun 1, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Oct 13, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 13, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 15, 2011 | No problems found | 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 1, 2018 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Failing drug products not rejected 21 CFR 211.165(f)
Drug products failing to meet established specifications and quality control criteria are not rejected. - 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. - Cleaning SOP/inspection 21 CFR 211.67(b)(6)
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Jun 13, 2014 inspection
- Annual visual exams of drug products 21 CFR 211.170(b)
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Registered with FDA for: analysis; manufacture.