FDA Inspection
Laboratorio Reig Jofre, S.A.Laboratorio Reig Jofre, S.A. – FDA Inspection, Apr 5, 2019
Record Details
This FDA Inspection record concerns Laboratorio Reig Jofre, S.A., with an inspection on April 5, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 9d6b5bb2-2cf7-4b18-b248-abd39b565945
Inspection Facts
- Inspection number
- 1086251
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)(1)Sampling and testing procedures described
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Laboratorio Reig Jofre, S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratorio Reig Jofre, S.A.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.