Atlas

Form 483

Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs Form 483, 2010-08-06

FDA issued a Form 483 to Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs on 2010-08-06 with 42 public-safe observations.

483· Form 483 issued42 observations

Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs · Santa Fe Springs, United States · Issued August 6, 2010

Overview

  • 42 public-safe observations are available for this inspection.
  • 40 structured CFR citations are represented.
  • 4 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

6 Aug 2010
21 CFR 111.12(c)

Personnel - education, training, experience

Cited by Arsen Karapetyan, Sundy Ven, Virgilio F Pacio, Andy B Lee

6 Aug 2010
21 CFR 111.15(b)(1)

Physical plant - clean and sanitary

Cited by Arsen Karapetyan, Sundy Ven, Virgilio F Pacio, Andy B Lee

6 Aug 2010
21 CFR 111.15(b)(2)

Physical plant - repair

Cited by Arsen Karapetyan, Sundy Ven, Virgilio F Pacio, Andy B Lee

6 Aug 2010
21 CFR 111.15(d)(2)

Pest control measures

Cited by Arsen Karapetyan, Sundy Ven, Virgilio F Pacio, Andy B Lee

6 Aug 2010
21 CFR 111.65

Quality control - packaged, labeled

Cited by Arsen Karapetyan, Sundy Ven, Virgilio F Pacio, Andy B Lee

Inspected site

TMTitan Medical Enterprises, Inc. DBA U.S. Apothecary LabsSanta Fe Springs, United States

Inspection team

AKArsen Karapetyan
SVSundy Ven
VFVirgilio F Pacio
ABAndy B Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.65Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 111.12(c)Cited across public-safe Form 483 observations1x
21 CFR 111.15(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.15(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.15(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.205(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.210(c)Cited across public-safe Form 483 observations1x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.260(g)Cited across public-safe Form 483 observations1x
21 CFR 111.320(a)Cited across public-safe Form 483 observations1x
21 CFR 111.325(a)Cited across public-safe Form 483 observations1x
21 CFR 111.365Cited across public-safe Form 483 observations1x
21 CFR 111.403Cited across public-safe Form 483 observations1x
21 CFR 111.410(b)Cited across public-safe Form 483 observations1x
21 CFR 111.415(e)Cited across public-safe Form 483 observations1x
21 CFR 111.460(a)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.75(h)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.46(c)Cited across public-safe Form 483 observations1x
21 CFR 211.52Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 42 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