Atlas

Form 483

Penn Herb Company, Ltd. Form 483, 2013-08-28

FDA issued a Form 483 to Penn Herb Company, Ltd. on 2013-08-28 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Penn Herb Company, Ltd. · Philadelphia, United States · Issued August 28, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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 Aug 2013
21 CFR 111.14(b)(2)

Personnel - records - training

Cited by Tania E Vizcaino, Raffi B Papazian

28 Aug 2013
21 CFR 111.70(c)(1)

In-process identity, purity, strength, composition

Cited by Tania E Vizcaino, Raffi B Papazian

Inspected site

PHPenn Herb Company, Ltd.Philadelphia, United States

Inspection team

TETania E Vizcaino
RBRaffi B Papazian

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.14(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.70(c)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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