OSO Bio Pharmaceuticals Manufacturing
Form 483 issued March 20, 2020 · Albuquerque, New Mexico
- Inspection
- Mar 16 – Mar 20, 2020
- Investigator
- Michael A. Charles
- Observations
- 2
- Pages
- 5
- FEI number
- 1643045
In short: On March 20, 2020, FDA issued a Form 483 with 2 observations to OSO Bio Pharmaceuticals Manufacturing in Albuquerque, New Mexico (FEI 1643045) after an inspection that ran Mar 16 – Mar 20, 2020. The investigator was Michael A. Charles. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 2 observations on this Form 483, mostly about production 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?
Michael A. Charles is named on this Form 483, for the inspection of Mar 16 – Mar 20, 2020. Each investigator has a profile showing what they cite most.
When was OSO Bio Pharmaceuticals Manufacturing inspected by FDA?
The inspection ran Mar 16 – Mar 20, 2020, and the Form 483 is dated March 20, 2020.
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.