Specialty Process Labs
Form 483 issued September 15, 2023 · Phoenix, Arizona
- Inspection
- Sep 11 – Sep 15, 2023
- Investigator
- Cecilia H. Kieu
- Observations
- 2
- Pages
- 4
- FEI number
- 3017888878
In short: On September 15, 2023, FDA issued a Form 483 with 2 observations to Specialty Process Labs in Phoenix, Arizona (FEI 3017888878) after an inspection that ran Sep 11 – Sep 15, 2023. The investigator was Cecilia H. Kieu. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to have documented procedures describing sampling, testing, and…
- 02
Your firm failed to design a documented, on-going stability testing program to monitor the stability characteristics…
This inspection in context
Cecilia H. Kieu
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmSpecialty Process Labs history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Process Labs?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Specialty Process Labs?
Cecilia H. Kieu is named on this Form 483, for the inspection of Sep 11 – Sep 15, 2023. Each investigator has a profile showing what they cite most.
When was Specialty Process Labs inspected by FDA?
The inspection ran Sep 11 – Sep 15, 2023, and the Form 483 is dated September 15, 2023.
How do I get the full Form 483 for Specialty Process Labs?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.