CeramTec GmbH Medical Products Division

FDA inspection history on file, 2023

1
Form 483

Every document, by year

  • Form 483

2023: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2023One Form 483.

Cited most

Across all CeramTec GmbH Medical Products Division observations on file

  • 21 CFR 803.17
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1
  • 21 CFR 820.75
    Process validation
    1

The complete CeramTec GmbH Medical Products Division file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Documents

1 on file, newest first
DateDocumentPrice
2023-01-19483 Form 483$99

FEI number 3001278222 · most recent document Jan 19, 2023

About CeramTec GmbH Medical Products Division

How many FDA Form 483s has CeramTec GmbH Medical Products Division received?

FDA Intel has 1 Form 483 on file for CeramTec GmbH Medical Products Division; the most recent is dated Jan 19, 2023.

When was CeramTec GmbH Medical Products Division last inspected by FDA?

The most recent FDA inspection document on file for CeramTec GmbH Medical Products Division is a Form 483 dated Jan 19, 2023.

What did FDA cite at CeramTec GmbH Medical Products Division?

The regulations cited most in the observations on file for CeramTec GmbH Medical Products Division are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.75 (Process validation), 1 time.