Form 483

Biocentric Lab LLC Form 483, 2026-06-11

FDA issued a Form 483 to Biocentric Lab LLC on 2026-06-11 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Biocentric Lab LLC · Grapevine, United States · Issued June 11, 2026

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

11 Jun 2026
21 CFR 1271.225

Verification/validation

Cited by Ramon L Gonzalez-Prieto

11 Jun 2026
21 CFR 1271.230(a)

Process validation procedures

Cited by Ramon L Gonzalez-Prieto

11 Jun 2026
21 CFR 1271.350(b)(3)

HCT/P Deviation Reporting Within 45 Days

Cited by Ramon L Gonzalez-Prieto

Inspected site

BLBiocentric Lab LLCGrapevine, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.225Cited across public-safe Form 483 observations1x
21 CFR 1271.230(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.350(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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