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Form 483

Bactolac Pharmaceutical, Inc. Form 483, 2015-06-25

FDA issued a Form 483 to Bactolac Pharmaceutical, Inc. on 2015-06-25 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Bactolac Pharmaceutical, Inc. · Hauppauge, United States · Issued June 25, 2015

Overview

  • 2 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.

25 Jun 2015
21 CFR 111.315(d)

Standard reference materials; criteria for selecting, QC

Cited by Eric J Reisenauer

25 Jun 2015
21 CFR 111.553

Written procedures - product complaint

Cited by Eric J Reisenauer

Inspected site

BPBactolac Pharmaceutical, Inc.Hauppauge, United States

Inspection team

EJEric J Reisenauer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.315(d)Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 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