FDA Inspection
Recipharm Strangnas ABRecipharm Strangnas AB – FDA Inspection, Sep 6, 2019
Record Details
This FDA Inspection record concerns Recipharm Strangnas AB, with an inspection on September 6, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 42f03dca-5d05-46ef-9382-3f2475c2af8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101934
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Recipharm Strangnas AB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Recipharm Strangnas AB
- FDA Inspection 1265346 - 2022-11-18
- FDA Inspection 1173099 - 2019-05-16
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