Specialty Process Labs
Form 483 issued January 26, 2024 · Phoenix, Arizona
- Investigators
- Aveese Philip Stafanos· Philip F. Istafanos
- Observations
- 6
- Pages
- 7
- FEI number
- 3017888878
In short: On January 26, 2024, FDA issued a Form 483 with 6 observations to Specialty Process Labs in Phoenix, Arizona (FEI 3017888878). The investigators were Aveese Philip Stafanos and Philip F. Istafanos. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Validation of manufacturing processes of…
- 02
Failure to investigate out-of-specifications of strength of liothyronine and levothyroxine during both accelerated and long-term stability…
- 03
Procedures for equipment cleaning validation failed to address microbiological contamination, detergent and/or solution…
- 04
There is lack of appropriate control to prevent unauthorized access to computers or related systems from…
This inspection in context
Aveese Philip Stafanos
1 document · 2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Arizona.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Process Labs?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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?
Aveese Philip Stafanos and Philip F. Istafanos are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Specialty Process Labs inspected by FDA?
This Form 483 is dated January 26, 2024.
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.