C S Bio Company
Form 483 issued December 7, 2015 · Menlo Park, California
- Inspection
- Nov 16 – Dec 7, 2015
- Investigator
- Lucila B. Nwatu
- Observations
- 9
- Pages
- 9
- FEI number
- 3000959260
In short: On December 7, 2015, FDA issued a Form 483 with 9 observations to C S Bio Company in Menlo Park, California (FEI 3000959260) after an inspection that ran Nov 16 – Dec 7, 2015. The investigator was Lucila B. Nwatu. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory' control records should be complete and include all data derived from all tests conducted to…
- 02
Materials should be handled and stored in a manner to prevent degradation…
- 03
Out-of-Specification (OOS) results obtained should be investigated and documented according to a written procedure and should…
- 04
Failure to adequately qualify your suppliers of critical API starting materials and demonstrate that the suppliers…
This inspection in context
Lucila B. Nwatu
18 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmC S Bio Company history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C S Bio Company?
FDA listed 9 observations on this Form 483, mostly about materials, quality system and production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected C S Bio Company?
Lucila B. Nwatu is named on this Form 483, for the inspection of Nov 16 – Dec 7, 2015. Each investigator has a profile showing what they cite most.
When was C S Bio Company inspected by FDA?
The inspection ran Nov 16 – Dec 7, 2015, and the Form 483 is dated December 7, 2015.
How do I get the full Form 483 for C S Bio Company?
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.