# FDA 483 - Biovectra, Inc. - February 17, 2017

Source: https://www.keypedia.com/records/483/biovectra-inc/773a5858-5c4c-456e-bdf5-e703c5faaff7

> FDA 483 for Biovectra, Inc. on February 17, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biovectra, Inc.
- Inspection Date: 2017-02-17
- Product Type: drugs
- Office Name: Office of Pharmaceutical Quality
- Summary: From February 13 to February 17, 2017, the Food and Drug Administration (FDA) conducted a regulatory inspection of BioVectra Inc., a manufacturing facility located in Charlottetown, Prince Edward Island, Canada. Following the inspection, the FDA issued a Form 483 to the company's president, Mr. Oliver Technow, detailing a significant observation regarding the facility's quality control operations. The primary issue identified was the failure of the firm to adhere to its established stability program procedures. Specifically, the FDA investigators found that stability testing for several batches of Bulk Active Pharmaceutical Ingredients (API) was consistently not completed in a timely manner as required by the company's own standard operating procedures. Inspection records revealed that multiple batches pulled for stability testing throughout 2016 had critical tests—including appearance, potency, pH levels, and other chemical analyses—that had either not been started months after the pull dates or were significantly delayed. These lapses in protocol suggest a lack of oversight in monitoring the long-term quality and integrity of the drug substances produced at the site. This observation falls under the regulatory framework of current Good Manufacturing Practices (cGMP), which ensures products are consistently produced and controlled. While the Form 483 is an initial report and not a final agency determination, BioVectra is required to provide a written response to the FDA. This response must detail the corrective actions the company plans to implement to ensure future adherence to stability testing timelines and the resolution of the identified procedural failures.

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## Related Officers

- [Chemist](https://www.keypedia.com/people/tonya-r-johnson/403d3eb6-758b-4c57-80cf-901359382588)
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Company: https://www.keypedia.com/companies/biovectra-inc/1e29a998-319e-49cb-bee2-bacea2c620ef

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality/c3303908-9657-4cd3-ae43-2458c98e8a64