Bentec Medical, Inc
Form 483 issued January 29, 2015 · Woodland, California
- Inspection
- Jan 13 – Jan 29, 2015
- Investigator
- Seema S. Singh
- Observations
- 5
- Pages
- 4
- FEI number
- 2939142
In short: On January 29, 2015, FDA issued a Form 483 with 5 observations to Bentec Medical, Inc in Woodland, California (FEI 2939142) after an inspection that ran Jan 13 – Jan 29, 2015. The investigator was Seema S. Singh. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and design controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
- 02
Procedures for corrective and preventive action…
- 03
A validated process was not reviewed and evaluated when changes…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Seema S. Singh
6 documents · 2015–2020
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmBentec Medical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bentec Medical, Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Bentec Medical, Inc?
Seema S. Singh is named on this Form 483, for the inspection of Jan 13 – Jan 29, 2015. Each investigator has a profile showing what they cite most.
When was Bentec Medical, Inc inspected by FDA?
The inspection ran Jan 13 – Jan 29, 2015, and the Form 483 is dated January 29, 2015.
How do I get the full Form 483 for Bentec Medical, 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.