OSO Bio Pharmaceuticals Manufacturing
FDA inspection history in Albuquerque, New Mexico, 2016 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2020: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Albuquerque, New Mexico.
- 2020–24Three Form 483s, at Albuquerque, New Mexico.
- 2022The longest 483 on file: 13 observations over 8 pages at Albuquerque, New Mexico.
Cited most
Across all OSO Bio Pharmaceuticals Manufacturing observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.42Design and construction features2
The complete OSO Bio Pharmaceuticals Manufacturing file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Albuquerque, New Mexico
Four Form 483s · 2016 to 2024 · 20 observations
Latest: Form 483, Jun 28, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-28 | 483 Form 483 | Albuquerque, New Mexico | 3 | $99 |
| 2022-04-11 | 483 Form 483 | Albuquerque, New Mexico | 13 | $99 |
| 2020-03-20 | 483 Form 483 | Albuquerque, New Mexico | 2 | $99 |
| 2016-12-07 | 483 Form 483 | Albuquerque, New Mexico | 2 | $99 |
Investigators on these documents
Alan P. Kurtzberg (1)Carolina D. Vasquez (1)Chani Broner (1)Michael A. Charles (1)Nicholas L. Hunt (1)Zhong Li (1)
FEI number 1643045 · most recent document Jun 28, 2024
About OSO Bio Pharmaceuticals Manufacturing
How many FDA Form 483s has OSO Bio Pharmaceuticals Manufacturing received?
FDA Intel has 4 Form 483s on file for OSO Bio Pharmaceuticals Manufacturing; the most recent is dated Jun 28, 2024.
When was OSO Bio Pharmaceuticals Manufacturing last inspected by FDA?
The most recent FDA inspection document on file for OSO Bio Pharmaceuticals Manufacturing is a Form 483 dated Jun 28, 2024, for the site in Albuquerque, New Mexico.
What did FDA cite at OSO Bio Pharmaceuticals Manufacturing?
The regulations cited most in the observations on file for OSO Bio Pharmaceuticals Manufacturing are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.160 (General requirements), 2 times.