# FDA 483 - Genzyme Corporation - September 04, 2020

Source: https://www.globalkeysolutions.net/records/483/genzyme-corporation/92fb5a72-64b2-4547-a360-5fbd53dbb20b

> FDA 483 for Genzyme Corporation on September 04, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genzyme Corporation
- Inspection Date: 2020-09-04
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Genzyme Corporation, a drug substance manufacturer in Framingham, MA, was cited for two observations during an FDA inspection. The inspection revealed inadequate maintenance of facilities and equipment, including issues with sterilization equipment, air filters, and diffusers. Additionally, the QC Microbiology Laboratory had uncertified equipment and failed to conduct logbook reviews according to established procedures.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/ying-xin-fan/905eacc9-1394-4215-9fbc-61c151c0debe)
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Company: https://www.globalkeysolutions.net/companies/genzyme-corporation/b597b205-d758-426b-bc64-09970b3a1b83

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd