Atlas

Form 483

Epimed International, Inc. Form 483, 2010-04-13

FDA issued a Form 483 to Epimed International, Inc. on 2010-04-13 with 6 public-safe observations.

483· Form 483 issued6 observations

Epimed International, Inc. · Johnstown, United States · Issued April 13, 2010

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

13 Apr 2010
21 CFR 803.18(b)(1)(ii)

Files do not contain copies of MDR forms

Cited by Catherine M Beer

13 Apr 2010
21 CFR 806.10(a)(2)

Report of violation of the Act (see 803.52(e)(9))

Cited by Catherine M Beer

13 Apr 2010
21 CFR 820.70(a)

Production processes

Cited by Catherine M Beer

13 Apr 2010
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Catherine M Beer

13 Apr 2010
21 CFR 820.100(b)

Documentation

Cited by Catherine M Beer

Inspected site

EIEpimed International, Inc.Johnstown, United States

Inspection team

CMCatherine M Beer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.18(b)(1)(ii)Cited across public-safe Form 483 observations1x
21 CFR 806.10(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.250(b)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

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