Purac Biochem BV
Form 483 issued December 11, 2015 · Gorinchem, Netherlands
- Inspection
- Dec 7 – Dec 11, 2015
- Investigator
- Satheesh Thomas
- Observations
- 6
- Pages
- 3
- FEI number
- 3002806633
In short: On December 11, 2015, FDA issued a Form 483 with 6 observations to Purac Biochem BV in Gorinchem, Netherlands (FEI 3002806633) after an inspection that ran Dec 7 – Dec 11, 2015. The investigator was Satheesh Thomas. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 3 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written testing program designed to assess the stability characteristics of the drug substance does not…
- 02
Validation of software are…
- 03
Piping and Instrumentation diagrams are not approved…
- 04
Lack of written test…
This inspection in context
Satheesh Thomas
3 documents · 2015–2018
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmPurac Biochem BV history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Purac Biochem BV?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Purac Biochem BV?
Satheesh Thomas is named on this Form 483, for the inspection of Dec 7 – Dec 11, 2015. Each investigator has a profile showing what they cite most.
When was Purac Biochem BV inspected by FDA?
The inspection ran Dec 7 – Dec 11, 2015, and the Form 483 is dated December 11, 2015.
How do I get the full Form 483 for Purac Biochem BV?
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.