Allay Pharmaceuticals, LLC
FDA inspection history across 2 sites, 2020 to 2021
- 2
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2020: one Form 483; 2021: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–21Two Form 483s and one warning letter, at Miami, Florida and Hialeah, Florida.
- 2020The longest 483 on file: 9 observations over 14 pages at Miami, Florida.
Cited most
Across all Allay Pharmaceuticals observations on file
- 21 CFR 8201
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.186(b)(9)Master production and control records1
The complete Allay Pharmaceuticals file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Miami, Florida
Two Form 483s · 2020 to 2021 · 11 observations
Latest: Form 483, Nov 15, 2021 →Hialeah, Florida
One warning letter and one close-out letter · 2021
Latest: Warning letter, Jan 27, 2021 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-11-15 | 483 Form 483 | Miami, Florida | 2 | $99 |
| 2021-01-27 | Warning letter Warning letter | Hialeah, Florida | — | $99 |
| 2020-05-15 | 483 Form 483 | Miami, Florida | 9 | $99 |
| Undated | Close-out Close-out letter | Hialeah, Florida | — | $99 |
Investigators on these documents
Clinton J. Lott (1)Jessica L. Pressley (1)Joanne E. King (1)
FEI number 3007007565 · most recent document Nov 15, 2021
About Allay Pharmaceuticals, LLC
How many FDA Form 483s has Allay Pharmaceuticals, LLC received?
FDA Intel has 2 Form 483s on file for Allay Pharmaceuticals, LLC; the most recent is dated Nov 15, 2021.
When was Allay Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Allay Pharmaceuticals, LLC is a Form 483 dated Nov 15, 2021, for the site in Miami, Florida.
What did FDA cite at Allay Pharmaceuticals, LLC?
The regulations cited most in the observations on file for Allay Pharmaceuticals, LLC are 21 CFR 820, 1 time; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.
Has Allay Pharmaceuticals, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Allay Pharmaceuticals, LLC; the most recent is dated Jan 27, 2021.