Overview
- 4 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
11 Mar 2020
FDCA 501(a)(2)(A)
Actionable microbial contamination, adjacent area
11 Mar 2020
FDCA 501(a)(2)(A)
Cleanliness, ISO-classified areas
11 Mar 2020
FDCA 501(a)(2)(A)
Improper gowning, contamination
11 Mar 2020
FDCA 501(a)(2)(A)
Use of non-pharmaceutical grade components
Inspected site
LVLa Vita Compounding Pharmacy, LLCSan Diego, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 4x |
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 4 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