# FDA 483 - Cilag AG - July 16, 2019

Source: https://www.keypedia.com/records/483/cilag-ag/008c538e-3e86-4f82-8d9a-bce597e8dfc4

> FDA 483 for Cilag AG on July 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cilag AG
- Inspection Date: 2019-07-16
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: The U.S. Food and Drug Administration (FDA) conducted an inspection of Cilag AG, a drug manufacturer based in Schaffhausen, Switzerland, from July 8 to July 16, 2019. This inspection resulted in the issuance of an FDA Form 483, detailing several observations regarding the firm's operations.

Key issues identified within the production system included the inadequate maintenance of equipment and utensils, specifically a 1-inch gap on a protective shield in a vial filling line, which could compromise product purity. Additionally, the company failed to follow established test procedures, as demonstrated by the omission of microbiological identification for an environmental sample that exceeded a warning level in a Grade C manufacturing area.

Within the laboratory system, deficiencies in record-keeping were noted. These included incomplete documentation for instrument calibration, with a balance used for weighing media missing its identification number in logs. Furthermore, laboratory batch records for endotoxin analysis lacked complete traceability information for the test tubes utilized. These observations suggest potential deviations from current good manufacturing practices, and Cilag AG is expected to thoroughly evaluate these findings and implement comprehensive corrective actions to ensure full compliance.

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## Related Officers

- [Santos E Camara, Investigator](https://www.keypedia.com/people/santos-e-camara-investigator/ba1192af-b020-46e7-8aad-366a0c541d1c)

Company: https://www.keypedia.com/companies/cilag-ag/acb7f670-89b9-4e40-a784-ed06b0282362

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa