# FDA 483 - Genzyme Corporation - September 04, 2020

Source: https://www.keypedia.com/records/483/genzyme-corporation/894c0fc4-69ad-498f-9313-26d2ae12d839

> 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: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Genzyme Corporation's drug substance manufacturing facility in Framingham, MA, conducted from August 26 to September 4, 2020, identified critical observations related to facility and equipment maintenance, and quality control procedures. Operating under Good Manufacturing Practices (GMP) standards, the inspection highlighted two primary areas requiring attention.

The first observation concerned inadequate maintenance of manufacturing facilities and equipment. This included a sterilization unit used for bioreactor probes that exhibited residue and lacked a routine cleaning procedure, an unsecured air return pre-filter in a raw material weighing booth, and several unfastened ceiling air supply diffuser screens within a critical clean space. These conditions raise concerns regarding environmental control and potential impact on product quality.

The second observation focused on the Quality Control Microbiology Laboratory, where equipment certification and logbook review processes were found to be deficient. Specifically, a Sartorius analytical balance was not certified for its minimum weigh amount, and multiple equipment logbooks for water baths had exceeded the company's specified timeframe for functional area review, indicating non-compliance with internal standard operating procedures.

As a result of these FDA Form 483 observations, Genzyme Corporation is required to implement comprehensive corrective actions to address these deficiencies, ensure proper upkeep of facilities and equipment, and strengthen quality control practices to maintain regulatory compliance for its drug substance manufacturing operations.

## Related Documents

- [EIR - 2020-09-04](https://www.keypedia.com/records/eir/genzyme-corporation/9e7a9f46-31eb-4d3b-9af7-a9f9dea767de)
- [483 - 2020-09-04](https://www.keypedia.com/records/483/genzyme-corporation/92fb5a72-64b2-4547-a360-5fbd53dbb20b)
- [EIR - 2022-06-25](https://www.keypedia.com/records/eir/genzyme-corporation/6eb86bff-8103-449e-b583-0fb676d5acb3)
- [483 - 2022-07-25](https://www.keypedia.com/records/483/genzyme-corporation/349b695a-f390-44c5-b321-aa0f01ee5183)
- [483 - 2022-07-25](https://www.keypedia.com/records/483/genzyme-corporation/23883a1e-c563-4d35-85ce-e1cb99b21cb1)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ying-xin-fan/905eacc9-1394-4215-9fbc-61c151c0debe)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/genzyme-corporation/b597b205-d758-426b-bc64-09970b3a1b83

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c