Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)

Form 483 issued January 17, 2017 · Ravensburg, Germany

Observations: 5
Pages: 2
FEI number: 3002270322

In short: On January 17, 2017, FDA issued a Form 483 with 5 observations to Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) in Ravensburg, Baden-Wuerttemberg (FEI 3002270322). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).

At a glance

Observations span 4 systems, led by quality system.

Quality system1

Laboratory controls1

Materials1

Facilities & equipment1

Other1

What FDA observed

Preview: the opening words of each observation

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

01
21 CFR 211.198 21 CFR 211.192
Investigations were incomplete and did not include a review of the firm's retain samples regarding product…
02
21 CFR 211.160
On January 11, 2017, I observed the sampling of and for total viable counts and endotoxin…
03
21 CFR 211.84
Your firm does not perform a specific identity test on incoming API's used in the drug…
04
21 CFR 211.68
Standalone computer software system does not have audit trail capabilities to independently record the operational history…

1 more observation

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

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This inspection in context

The firm

Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.198

See how FDA wrote the same problem up elsewhere.

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Questions about this 483

What did FDA find at Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)?

FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.

When was Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) inspected by FDA?

This Form 483 is dated January 17, 2017.

How do I get the full Form 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)?

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