Lonza Tampa LLC

Form 483 issued September 29, 2023 · TAMPA, Florida

Observations
1
Pages
2
FEI number
3001549109

In short: On September 29, 2023, FDA issued a Form 483 with 1 observation to Lonza Tampa LLC in TAMPA, Florida (FEI 3001549109). Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).

At a glance

1 of 1 observations on this 483 concern quality system.

Quality system1

Most cited: 21 CFR 211.22(d) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    The responsibilities and procedures applicable to the quality control unit…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Lonza Tampa LLC?

FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.

When was Lonza Tampa LLC inspected by FDA?

This Form 483 is dated September 29, 2023.

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