FDA Intel

Surefil, LLC

Form 483 issued November 10, 2021 · Grand Rapids, Michigan

Observations
7
Pages
6
FEI number
3005649771

In short: On November 10, 2021, FDA issued a Form 483 with 7 observations to Surefil, LLC in Grand Rapids, Michigan (FEI 3005649771). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).

At a glance

Quality system and laboratory controls account for 6 of 7 observations.

Quality system3
Laboratory controls3
Production1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit are not in…

  2. 02
    21 CFR 211.25(a)

    Employees are not given training in…

  3. 03
    21 CFR 211.180(e)

    EMPLOYEE{S) SIGNATURE aceon Records are not maintained so that data therein can be reviewed at least…

  4. 04
    21 CFR 211.188(b)

    The batch production and control records are deficient in that they do not include documentation of…

3 more observations

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

Get the full 483

This inspection in context

The firm

Surefil, LLC history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.22(d)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Surefil, LLC?

FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.

When was Surefil, LLC inspected by FDA?

This Form 483 is dated November 10, 2021.

How do I get the full Form 483 for Surefil, LLC?

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