Specialty Formulations and Manufacturing LLC
FDA inspection history in Phoenix, Arizona, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Phoenix, Arizona.
Cited most
Across all Specialty Formulations and Manufacturing observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.188(b)Batch production and control records1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Specialty Formulations and Manufacturing file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Phoenix, Arizona
One Form 483 · 2019 · 7 observations
Latest: Form 483, Feb 20, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-02-20 | 483 Form 483 | Phoenix, Arizona | 7 | $99 |
Investigators on these documents
FEI number 3008274683 · most recent document Feb 20, 2019
About Specialty Formulations and Manufacturing LLC
How many FDA Form 483s has Specialty Formulations and Manufacturing LLC received?
FDA Intel has 1 Form 483 on file for Specialty Formulations and Manufacturing LLC; the most recent is dated Feb 20, 2019.
When was Specialty Formulations and Manufacturing LLC last inspected by FDA?
The most recent FDA inspection document on file for Specialty Formulations and Manufacturing LLC is a Form 483 dated Feb 20, 2019, for the site in Phoenix, Arizona.
What did FDA cite at Specialty Formulations and Manufacturing LLC?
The regulations cited most in the observations on file for Specialty Formulations and Manufacturing LLC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.