Specialty Process Labs
FDA inspection history in Phoenix, Arizona, 2021 to 2024
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2021: one Form 483; 2022: one warning letter; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–24Three Form 483s and one warning letter, at Phoenix, Arizona.
- 2021The longest 483 on file: 11 observations over 7 pages at Phoenix, Arizona.
Cited most
Across all Specialty Process Labs observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
The complete Specialty Process Labs 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
Phoenix, Arizona
Three Form 483s and one warning letter · 2021 to 2024 · 13 observations
Latest: Form 483, Jan 26, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-26 | 483 Form 483 | Phoenix, Arizona | — | $99 |
| 2023-09-15 | 483 Form 483 | Phoenix, Arizona | 2 | $99 |
| 2022-05-03 | Warning letter Warning letter | Phoenix, Arizona | — | $99 |
| 2021-11-19 | 483 Form 483 | Phoenix, Arizona | 11 | $99 |
Investigators on these documents
Aveese Philip Stafanos (1)Cecilia H. Kieu (1)Christopher M. Jenner (1)Philip F. Istafanos (1)
FEI number 3017888878 · most recent document Jan 26, 2024
About Specialty Process Labs
How many FDA Form 483s has Specialty Process Labs received?
FDA Intel has 3 Form 483s on file for Specialty Process Labs; the most recent is dated Jan 26, 2024.
When was Specialty Process Labs last inspected by FDA?
The most recent FDA inspection document on file for Specialty Process Labs is a Form 483 dated Jan 26, 2024, for the site in Phoenix, Arizona.
What did FDA cite at Specialty Process Labs?
The regulations cited most in the observations on file for Specialty Process Labs are 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times.
Has Specialty Process Labs received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Specialty Process Labs; the most recent is dated May 3, 2022.