FDA Intel

Forcemech International LLC

Form 483 issued April 16, 2021 · Pearland, Texas

Inspection
Apr 6 – Apr 16, 2021
Investigator
Jocelyn C. Turner
Observations
11
Pages
17
FEI number
3013934051

In short: On April 16, 2021, FDA issued a Form 483 with 11 observations to Forcemech International LLC in Pearland, Texas (FEI 3013934051) after an inspection that ran Apr 6 – Apr 16, 2021. The investigator was Jocelyn C. Turner. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).

At a glance

CAPA and production & process controls account for 8 of 11 observations.

CAPA5
Production & process controls3
Management controls3

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 820.80(b)

    Procedures for acceptance of incoming product…

  3. 03
    21 CFR 820.198(a)

    Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…

  4. 04
    21 CFR 820.100(a)

    Procedures for corrective and preventive action…

7 more observations

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

Get the full 483

This inspection in context

The investigator

Jocelyn C. Turner

10 documents · 2015–2026

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

The firm

Forcemech International LLC 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 803.17(a)(2)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Forcemech International LLC?

FDA listed 11 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.

Who inspected Forcemech International LLC?

Jocelyn C. Turner is named on this Form 483, for the inspection of Apr 6 – Apr 16, 2021. Each investigator has a profile showing what they cite most.

When was Forcemech International LLC inspected by FDA?

The inspection ran Apr 6 – Apr 16, 2021, and the Form 483 is dated April 16, 2021.

How do I get the full Form 483 for Forcemech International LLC?

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