Company
SwedenApotek Produktion & Laboratorier AB, Kungens Kurva, Sweden – FDA Inspections
Inspection records and compliance data for Apotek Produktion & Laboratorier AB in Kungens Kurva. 5 FDA inspections on record, 1 Form 483, last inspected April 28, 2022.
Company Profile
This profile covers Apotek Produktion & Laboratorier AB based in Kungens Kurva, Sweden.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected December 15, 2011. Last inspected April 28, 2022.
Most cited issue areas
- Annual visual exams of drug products1 inspection
- Cleaning SOP/inspection1 inspection
- Computer control of master formula records1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 28, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1204691 |
| June 1, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1053895 |
| October 13, 2015 | VAI | Human Drugs · Drug Quality Assurance | 947078 |
| June 13, 2014 | VAI | Human Drugs · Drug Quality Assurance | 886202 |
| December 15, 2011 | NAI | Human Drugs · Drug Quality Assurance | 763956 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Apotek Produktion & Laboratorier AB
FEI Number
3004967053
Address
Prismavagen 2, Kungens Kurva, Sweden
Country
Sweden
ID: 3a0cebb5-5abe-4336-91fb-faaef7f8ed1c