FDA Inspection
Altan Pharmaceuticals, S.A.Altan Pharmaceuticals, S.A. – FDA Inspection, May 17, 2019
Record Details
This FDA Inspection record concerns Altan Pharmaceuticals, S.A., with an inspection on May 17, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- Person
- Angela E. Glenn (Issuing Officer)
View Company Profile
ID · 712f0948-1ddc-4706-bb85-308802a2d259
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090106
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.194(a)Complete test data included in records
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