OSO Bio Pharmaceuticals Manufacturing
Form 483 issued December 7, 2016 · Albuquerque, New Mexico
- Inspection
- Nov 28 – Dec 7, 2016
- Observations
- 2
- Pages
- 3
- FEI number
- 1643045
In short: On December 7, 2016, FDA issued a Form 483 with 2 observations to OSO Bio Pharmaceuticals Manufacturing in Albuquerque, New Mexico (FEI 1643045) after an inspection that ran Nov 28 – Dec 7, 2016. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b) (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 02
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
This inspection in context
Questions about this 483
What did FDA find at OSO Bio Pharmaceuticals Manufacturing?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was OSO Bio Pharmaceuticals Manufacturing inspected by FDA?
The inspection ran Nov 28 – Dec 7, 2016, and the Form 483 is dated December 7, 2016.
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.