Cytovance Biologics, Inc.
Form 483 issued May 9, 2019 · Oklahoma City, Oklahoma
- Inspection
- May 1 – May 9, 2019
- Investigator
- Margaret M. Annes
- Observations
- 3
- Pages
- 3
- FEI number
- 3006341547
In short: On May 9, 2019, FDA issued a Form 483 with 3 observations to Cytovance Biologics, Inc. in Oklahoma City, Oklahoma (FEI 3006341547) after an inspection that ran May 1 – May 9, 2019. The investigator was Margaret M. Annes. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to thoroughly review and/or conduct adequate investigations into any…
- 02
Equipment used in the manufacture of active pharmaceutical ingredients…
- 03
Production personnel were not practicing good…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmCytovance Biologics, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cytovance Biologics, Inc.?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Cytovance Biologics, Inc.?
Margaret M. Annes is named on this Form 483, for the inspection of May 1 – May 9, 2019. Each investigator has a profile showing what they cite most.
When was Cytovance Biologics, Inc. inspected by FDA?
The inspection ran May 1 – May 9, 2019, and the Form 483 is dated May 9, 2019.
How do I get the full Form 483 for Cytovance Biologics, Inc.?
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.