FDA Intel

CooperSurgical, Inc.

Form 483 issued July 15, 2021 · Trumbull, Connecticut

Inspection
Jul 7 – Jul 15, 2021
Investigator
Stephen C. Smith
Observations
4
Pages
7
FEI number
1216677

In short: On July 15, 2021, FDA issued a Form 483 with 4 observations to CooperSurgical, Inc. in Trumbull, Connecticut (FEI 1216677) after an inspection that ran Jul 7 – Jul 15, 2021. The investigator was Stephen C. Smith. Most observations concern production & process controls and cAPA.

At a glance

Production & process controls and capa account for 4 of 4 observations.

Production & process controls2
CAPA2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.120(d)

    Labeling and packaging operations were not controlled…

  2. 02
    21 CFR 803.50(a)(2)

    An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…

  3. 03
    21 CFR 820.90(b)(1)

    Procedures that define the responsibility for review and the authority for the disposition of nonconforming product…

  4. 04
    21 CFR 820.70(c)

    Procedures to control environmental conditions have…

The full 483

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

Get the full 483

This inspection in context

The investigator

Stephen C. Smith

4 documents · 2015–2021

Cites 803.30 (if i am a user facility, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in New Hampshire.

The firm

CooperSurgical, Inc. history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.120(d)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at CooperSurgical, Inc.?

FDA listed 4 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 CooperSurgical, Inc.?

Stephen C. Smith is named on this Form 483, for the inspection of Jul 7 – Jul 15, 2021. Each investigator has a profile showing what they cite most.

When was CooperSurgical, Inc. inspected by FDA?

The inspection ran Jul 7 – Jul 15, 2021, and the Form 483 is dated July 15, 2021.

How do I get the full Form 483 for CooperSurgical, Inc.?

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