FDA Intel

SCS Direct Inc

Form 483 issued August 23, 2016 · Trumbull, Connecticut

Inspection
Aug 9 – Aug 23, 2016
Investigator
Dien N. Nguyen
Observations
5
Pages
3
FEI number
3012113857

In short: On August 23, 2016, FDA issued a Form 483 with 5 observations to SCS Direct Inc in Trumbull, Connecticut (FEI 3012113857) after an inspection that ran Aug 9 – Aug 23, 2016. The investigator was Dien N. Nguyen. Most observations concern quality system and materials.

At a glance

4 of 5 observations on this 483 concern quality system.

Quality system4
Materials1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.198(a)

    Procedures describing the handling of all written and oral complaints regarding a drug…

  2. 02
    21 CFR 211.22(a)

    There is no quality…

  3. 03
    21 CFR 211.25(a)

    Employees are not given training in the particular operations they perform as part of their function…

  4. 04
    21 CFR 211.150(b)

    A system by which the distribution of each lot of drug product can be readily determined…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Dien N. Nguyen

6 documents · 2016–2018

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Connecticut.

The firm

SCS Direct Inc history

All 4 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.198(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at SCS Direct Inc?

FDA listed 5 observations on this Form 483, mostly about quality system and materials. The opening words of each observation are shown on this page.

Who inspected SCS Direct Inc?

Dien N. Nguyen is named on this Form 483, for the inspection of Aug 9 – Aug 23, 2016. Each investigator has a profile showing what they cite most.

When was SCS Direct Inc inspected by FDA?

The inspection ran Aug 9 – Aug 23, 2016, and the Form 483 is dated August 23, 2016.

How do I get the full Form 483 for SCS Direct 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.

$99Get it free