Signature Formulations LLC
FDA inspection history in Phoenix, Arizona, 2017 to 2026
- 3
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2017: one Form 483; 2018: one close-out letter; 2021: one Form 483; 2023: one Form 483; 2026: two warning letters.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18One Form 483 and one close-out letter, at Phoenix, Arizona.
- 2017The longest 483 on file: 10 observations over 7 pages at Phoenix, Arizona.
- 2021–23Two Form 483s, at Phoenix, Arizona.
- 2026Two warning letters, at Phoenix, Arizona.
Cited most
Across all Signature Formulations observations on file
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.166Stability testing3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.160(a)General requirements2
The complete Signature Formulations file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Phoenix, Arizona
Three Form 483s, two warning letters and one close-out letter · 2017 to 2026 · 23 observations
Latest: Warning letter, Oct 1, 2026 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-10-01 | Warning letter Warning letter | Phoenix, Arizona | — | $99 |
| 2026-01-21 | Warning letter Warning letter | Phoenix, Arizona | — | $99 |
| 2023-11-22 | 483 Form 483 | Phoenix, Arizona | 6 | $99 |
| 2021-09-30 | 483 Form 483 | Phoenix, Arizona | 7 | $99 |
| 2018-07-31 | Close-out Close-out letter | Phoenix, Arizona | — | $99 |
| 2017-11-09 | 483 Form 483 | Phoenix, Arizona | 10 | $99 |
Investigators on these documents
Alan M. Barker (1)Christopher M. Jenner (1)Nicholas L. Hunt (1)
FEI number 3011368010 · most recent document Oct 1, 2026
About Signature Formulations LLC
How many FDA Form 483s has Signature Formulations LLC received?
FDA Intel has 3 Form 483s on file for Signature Formulations LLC; the most recent is dated Nov 22, 2023.
When was Signature Formulations LLC last inspected by FDA?
The most recent FDA inspection document on file for Signature Formulations LLC is a Form 483 dated Nov 22, 2023, for the site in Phoenix, Arizona.
What did FDA cite at Signature Formulations LLC?
The regulations cited most in the observations on file for Signature Formulations LLC are 21 CFR 211.100 (Written procedures; deviations), 5 times; 21 CFR 211.165 (Testing and release for distribution), 3 times; 21 CFR 211.166 (Stability testing), 3 times.
Has Signature Formulations LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Signature Formulations LLC; the most recent is dated Oct 1, 2026.