OSO Bio Pharmaceuticals Manufacturing
Form 483 issued June 28, 2024 · Albuquerque, New Mexico
- Inspection
- Jun 20 – Jun 28, 2024
- Investigators
- Carolina D. Vasquez· Nicholas L. Hunt
- Observations
- 3
- Pages
- 3
- FEI number
- 1643045
In short: On June 28, 2024, FDA issued a Form 483 with 3 observations to OSO Bio Pharmaceuticals Manufacturing in Albuquerque, New Mexico (FEI 1643045) after an inspection that ran Jun 20 – Jun 28, 2024. The investigators were Carolina D. Vasquez and Nicholas L. Hunt. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Carolina D. Vasquez
9 documents · 2022–2026
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in California.
The firmOSO Bio Pharmaceuticals Manufacturing history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OSO Bio Pharmaceuticals Manufacturing?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected OSO Bio Pharmaceuticals Manufacturing?
Carolina D. Vasquez and Nicholas L. Hunt are named on this Form 483, for the inspection of Jun 20 – Jun 28, 2024. Each investigator has a profile showing what they cite most.
When was OSO Bio Pharmaceuticals Manufacturing inspected by FDA?
The inspection ran Jun 20 – Jun 28, 2024, and the Form 483 is dated June 28, 2024.
How do I get the full Form 483 for OSO Bio Pharmaceuticals Manufacturing?
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.