Atlas

Form 483

American Antibiotics, Inc. Form 483, 2014-12-19

FDA issued a Form 483 to American Antibiotics, Inc. on 2014-12-19 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

American Antibiotics, Inc. · Baltimore, United States · Issued December 19, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

19 Dec 2014
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Toyin B Oladimeji, Eric L Dong

19 Dec 2014
21 CFR 211.67(b)

Written procedures fail to include

Cited by Toyin B Oladimeji, Eric L Dong

19 Dec 2014
21 CFR 211.68(b)

Computer control of master formula records

Cited by Toyin B Oladimeji, Eric L Dong

Inspected site

AAAmerican Antibiotics, Inc.Baltimore, United States

Inspection team

TBToyin B Oladimeji
ELEric L Dong

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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