Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-11-15.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Oct 2021 – 15 Nov 2021 | Human Drugs | 483 | View 483 → |
| 5 May 2020 – 15 May 2020 | Human Drugs | WL | View 483 → |
| 8 Jan 2018 – 17 Jan 2018 | Human Drugs | 483 | View 483 → |
| 12 Oct 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Nov 2021
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Joanne E King, Clinton J Lott
15 Nov 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Joanne E King, Clinton J Lott
15 May 2020
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jessica L Pressley, Ileana Barreto-Pettit
15 May 2020
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jessica L Pressley, Ileana Barreto-Pettit
15 May 2020
21 CFR 211.166(a)
Written program not followed
Cited by Jessica L Pressley, Ileana Barreto-Pettit
Investigators
FDA investigators tied to this site in the record.
Ileana Barreto-Pettit2 insp.
Joanne E King1 insp.
Clinton J Lott1 insp.
Jessica L Pressley1 insp.
Jennifer Lalama1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Allay Pharmaceuticals, LLC's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat