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Medical Specialties Distributors LLC

Form 483 issued July 9, 2018 · Hanover Park, Illinois

Observations
3
Pages
4

In short: On July 9, 2018, FDA issued a Form 483 with 3 observations to Medical Specialties Distributors LLC in Hanover Park, Illinois. Most observations concern management controls and cAPA.

At a glance

2 of 3 observations on this 483 concern management controls.

Management controls2
CAPA1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 820.25

    Procedures for training and identifying training needs have…

  2. 02
    21 CFR 820.22

    Procedures for quality audits have not been adequately established. “f- Hes few, juberna| anelst sehr huls…

  3. 03
    21 CFR 820.100

    Procedures for corrective and preventive action have…

The full 483

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This inspection in context

The firm

Medical Specialties Distributors LLC history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.25

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Questions about this 483

What did FDA find at Medical Specialties Distributors LLC?

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

When was Medical Specialties Distributors LLC inspected by FDA?

This Form 483 is dated July 9, 2018.

How do I get the full Form 483 for Medical Specialties Distributors LLC?

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