Form 483

Blaine Labs Inc Form 483, 2010-08-12

FDA issued a Form 483 to Blaine Labs Inc on 2010-08-12 with 5 public-safe observations.

483· Form 483 issued5 observations

Blaine Labs Inc · Santa Fe Springs, United States · Issued August 12, 2010

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

12 Aug 2010
21 CFR 211.25(a)

GMP Training Frequency

Cited by Virgilio F Pacio

12 Aug 2010
21 CFR 211.100(a)

Approval and review of procedures

Cited by Virgilio F Pacio

12 Aug 2010
21 CFR 211.137(a)

Expiration date lacking

Cited by Virgilio F Pacio

12 Aug 2010
21 CFR 211.166(a)

Results not used for expiration dates, storage cond.

Cited by Virgilio F Pacio

12 Aug 2010
21 CFR 211.198(a)

Complaints reviewed by Quality Control Unit

Cited by Virgilio F Pacio

Inspected site

BLBlaine Labs IncSanta Fe Springs, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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