Atlas

Form 483

Allay Pharmaceuticals, LLC Form 483, 2018-01-17

FDA issued a Form 483 to Allay Pharmaceuticals, LLC on 2018-01-17 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Allay Pharmaceuticals, LLC · Hialeah, United States · Issued January 17, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

17 Jan 2018
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Jennifer Lalama

17 Jan 2018
21 CFR 211.84(d)(3)

Establish reliability of supplier's C of A

Cited by Jennifer Lalama

Inspected site

APAllay Pharmaceuticals, LLCHialeah, United States

Inspection team

JLJennifer Lalama

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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