FDA Intel

Turncare, Inc

Form 483 issued June 26, 2023 · Pompton Plains, New Jersey

Inspection
May 16 – Jun 26, 2023
Investigator
Monica L. Gutierrez
Observations
9
Pages
10
FEI number
3013682457

In short: On June 26, 2023, FDA issued a Form 483 with 9 observations to Turncare, Inc in Pompton Plains, New Jersey (FEI 3013682457) after an inspection that ran May 16 – Jun 26, 2023. The investigator was Monica L. Gutierrez. Most observations concern cAPA and management controls.

At a glance

CAPA and management controls account for 6 of 9 observations.

CAPA3
Management controls3
Records & documents2
Production & process controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 803.17(a)(2)

    The written MDR procedure does not include an internal system which provides for a standardized review…

  2. 02
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

  3. 03
    21 CFR 820.90(a)

    Procedures have not been adequately established to control product that does not…

  4. 04
    21 CFR 820.72(a)

    Procedures to ensure equipment is routinely calibrated have…

5 more observations

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

Get the full 483

This inspection in context

The investigator

Monica L. Gutierrez

4 documents · 2023–2025

Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.

The firm

Turncare, Inc history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 803.17(a)(2)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Turncare, Inc?

FDA listed 9 observations on this Form 483, mostly about cAPA, management controls and records & documents. The opening words of each observation are shown on this page.

Who inspected Turncare, Inc?

Monica L. Gutierrez is named on this Form 483, for the inspection of May 16 – Jun 26, 2023. Each investigator has a profile showing what they cite most.

When was Turncare, Inc inspected by FDA?

The inspection ran May 16 – Jun 26, 2023, and the Form 483 is dated June 26, 2023.

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

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