Form 483

La Vita Compounding Pharmacy, LLC Form 483, 2018-06-08

FDA issued a Form 483 to La Vita Compounding Pharmacy, LLC on 2018-06-08 with 5 public-safe observations.

483· Form 483 issuedHuman Drugs5 observations

La Vita Compounding Pharmacy, LLC · San Diego, United States · Issued June 8, 2018

Overview

  • 5 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

8 Jun 2018
FDCA 501(a)(2)(A)

Ceiling tiles, cleanroom

Cited by Roger F Zabinski

8 Jun 2018
FDCA 501(a)(2)(A)

Disinfecting materials, aseptic processing area

Cited by Roger F Zabinski

8 Jun 2018
FDCA 501(a)(2)(A)

Dust-collecting overhangs, surrounding area of ISO 5

Cited by Roger F Zabinski

8 Jun 2018
FDCA 501(a)(2)(A)

Inadequate control, construction adjacent to drug production

Cited by Roger F Zabinski

8 Jun 2018
FDCA 501(a)(2)(A)

Personnel habits, contamination

Cited by Roger F Zabinski

Inspected site

LVLa Vita Compounding Pharmacy, LLCSan Diego, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 501(a)(2)(A)Cited across public-safe Form 483 observations5x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 5 observations

The source PDF, 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