Form 483

Transfer Technology, Inc. Form 483, 2019-10-11

FDA issued a Form 483 to Transfer Technology, Inc. on 2019-10-11 with 46 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health46 observations

Transfer Technology, Inc. · Huntington Beach, United States · Issued October 11, 2019

Overview

  • 46 public-safe observations are available for this inspection.
  • 12 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.

11 Oct 2019
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Kevin N Tran

11 Oct 2019
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Kevin N Tran

11 Oct 2019
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Kevin N Tran

11 Oct 2019
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Kevin N Tran

11 Oct 2019
21 CFR 820.250(b)

Sampling plans

Cited by Kevin N Tran

Inspected site

TTTransfer Technology, Inc.Huntington Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.181Cited across public-safe Form 483 observations4x
21 CFR 820.184Cited across public-safe Form 483 observations4x
21 CFR 820.250(b)Cited across public-safe Form 483 observations4x
21 CFR 820.30(c)Cited across public-safe Form 483 observations4x
21 CFR 820.30(g)Cited across public-safe Form 483 observations4x
21 CFR 820.30(h)Cited across public-safe Form 483 observations4x
21 CFR 820.50(a)(1)Cited across public-safe Form 483 observations4x
21 CFR 820.75(a)Cited across public-safe Form 483 observations4x
21 CFR 820.80(d)Cited across public-safe Form 483 observations4x
21 CFR 820.90(a)Cited across public-safe Form 483 observations4x
21 CFR 820.30(i)Cited across public-safe Form 483 observations3x
21 CFR 820.40Cited across public-safe Form 483 observations3x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 46 observations

The source PDF and every observation in full, 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