# FDA 483 - Mission Pharmacal Company - May 25, 2012

Source: https://www.keypedia.com/records/483/mission-pharmacal-company/0baf761c-5141-4187-9f2f-099e78a6b8f1

> FDA 483 for Mission Pharmacal Company on May 25, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mission Pharmacal Company
- Inspection Date: 2012-05-25
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Mission Pharmacal Co. in Boerne, TX, was cited for significant deficiencies in its quality system and production processes during an FDA inspection. The firm failed to submit NDA Field Alert Reports, maintain complete complaint records, and conduct thorough investigations into product failures. Additionally, issues were noted with process validation, including a lack of statistical rationale for sampling sites and inadequate in-process controls for blend uniformity.

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- [483 - 2019-04-04](https://www.keypedia.com/records/483/mission-pharmacal-company/de4b9fd5-1991-46a8-aef1-60b534e3f5c9)
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## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

Company: https://www.keypedia.com/companies/mission-pharmacal-company/91da96fe-b7e4-449c-b2cc-53a57bd7f2b6

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9