FDA Intel

Steritec Products Mfc. Co., Inc

Form 483 issued February 1, 2017 · Englewood, Colorado

Inspection
Jan 26 – Feb 1, 2017
Investigators
Kathleen S. Tormey· Vicky L. Cruz
Observations
3
Pages
2
FEI number
1000125215

In short: On February 1, 2017, FDA issued a Form 483 with 3 observations to Steritec Products Mfc. Co., Inc in Englewood, Colorado (FEI 1000125215) after an inspection that ran Jan 26 – Feb 1, 2017. The investigators were Kathleen S. Tormey and Vicky L. Cruz. Most observations concern production & process controls and cAPA.

At a glance

2 of 3 observations on this 483 concern production & process controls.

Production & process controls2
CAPA1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

  2. 02
    21 CFR 820.80(b)

    Procedures for acceptance of incoming product have…

  3. 03
    21 CFR 820.72(a)

    Procedures to ensure equipment is routinely maintained have not…

The full 483

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

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This inspection in context

The investigator

Kathleen S. Tormey

2 documents · 2015–2017

Cites 820 more than any other section. Most of their documents are for sites in Canada.

The firm

Steritec Products Mfc. Co., Inc history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.100(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Steritec Products Mfc. Co., Inc?

FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.

Who inspected Steritec Products Mfc. Co., Inc?

Kathleen S. Tormey and Vicky L. Cruz are named on this Form 483, for the inspection of Jan 26 – Feb 1, 2017. Each investigator has a profile showing what they cite most.

When was Steritec Products Mfc. Co., Inc inspected by FDA?

The inspection ran Jan 26 – Feb 1, 2017, and the Form 483 is dated February 1, 2017.

How do I get the full Form 483 for Steritec Products Mfc. Co., Inc?

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