Overview
- 8 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
28 Jan 2020
21 CFR 111.14(b)(2)
Personnel - records - training date, type, persons
Cited by Santos E Camara, Steve Y Rhieu
28 Jan 2020
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Santos E Camara, Steve Y Rhieu
28 Jan 2020
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Santos E Camara, Steve Y Rhieu
28 Jan 2020
21 CFR 211.192
Quality control unit review of records
Cited by Santos E Camara, Steve Y Rhieu
Inspected site
LFLaboratorios Farmalan, S.A.Villaquilambre, Spain
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere