OSO Bio Pharmaceuticals Manufacturing
Form 483 issued April 11, 2022 · Albuquerque, New Mexico
- Inspection
- Apr 4 – Apr 11, 2022
- Investigators
- Alan P. Kurtzberg· Chani Broner· Zhong Li
- Observations
- 13
- Pages
- 8
- FEI number
- 1643045
In short: On April 11, 2022, FDA issued a Form 483 with 13 observations to OSO Bio Pharmaceuticals Manufacturing in Albuquerque, New Mexico (FEI 1643045) after an inspection that ran Apr 4 – Apr 11, 2022. The investigators were Alan P. Kurtzberg, Chani Broner and Zhong Li. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 8 of 13 observations.
Most cited: 21 CFR 211.113 (3×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Written records of investigations into unexplained discrepancies do not always include…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OSO Bio Pharmaceuticals Manufacturing?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected OSO Bio Pharmaceuticals Manufacturing?
Alan P. Kurtzberg, Chani Broner and Zhong Li are named on this Form 483, for the inspection of Apr 4 – Apr 11, 2022. Each investigator has a profile showing what they cite most.
When was OSO Bio Pharmaceuticals Manufacturing inspected by FDA?
The inspection ran Apr 4 – Apr 11, 2022, and the Form 483 is dated April 11, 2022.
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.