Atlas

Form 483

U.S. Navy Medicine Readiness and Training Command Rota Spain Form 483, 2019-05-14

FDA issued a Form 483 to U.S. Navy Medicine Readiness and Training Command Rota Spain on 2019-05-14 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

U.S. Navy Medicine Readiness and Training Command Rota Spain · Rota, Spain · Issued May 14, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

14 May 2019
21 CFR 606.100(c)

Record review prior to release

Cited by La-Tasha M Gunter

14 May 2019
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by La-Tasha M Gunter

14 May 2019
21 CFR 606.100(c)

Record review prior to release

Cited by La-Tasha M Gunter

14 May 2019
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by La-Tasha M Gunter

Inspected site

UNU.S. Navy Medicine Readiness and Training Command Rota SpainRota, Spain

Inspection team

LMLa-Tasha M Gunter

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(c)Cited across public-safe Form 483 observations2x
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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