# FDA 483 - Mission Pharmacal Company - September 22, 2022

Source: https://www.keypedia.com/records/483/mission-pharmacal-company/c1fa42f1-b5d4-43b9-a7ab-c65cbe41084c

> FDA 483 for Mission Pharmacal Company on September 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mission Pharmacal Company
- Inspection Date: 2022-09-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Mission Pharmacal Company in Boerne, TX, a drug product manufacturer, received two observations during an FDA inspection. The facility was cited for inadequate pest control, with live insects and glue boards found in a drug product coating room. Additionally, the firm failed to maintain written records and conduct investigations for unexplained discrepancies, specifically regarding a pinhole leak in manufacturing equipment.

## Related Documents

- [483 - 2012-05-25](https://www.keypedia.com/records/483/mission-pharmacal-company/0baf761c-5141-4187-9f2f-099e78a6b8f1)
- [483 - 2014-02-07](https://www.keypedia.com/records/483/mission-pharmacal-company/4a5b0198-5b64-4f4b-8326-3e1ac06b0f95)
- [EIR - 2014-02-07](https://www.keypedia.com/records/eir/mission-pharmacal-company/c93b376c-87a4-4f1c-a091-b28dd4af1e17)
- [EIR - 2019-04-04](https://www.keypedia.com/records/eir/mission-pharmacal-company/e3fc2291-f7d5-4e0f-821f-ca635812b960)
- [EIR - 2017-05-04](https://www.keypedia.com/records/eir/mission-pharmacal-company/3401cfdc-0828-4576-a5a3-4e3347c881be)

## Related Officers

- [Michelle A. Krayer](https://www.keypedia.com/people/michelle-a-krayer/c68b88a6-d3d3-4407-867b-81b92b7ce977)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab