# FDA 483 - Professional Compounding Centers of America dba PCCA - April 21, 2023

Source: https://www.keypedia.com/records/483/professional-compounding-centers-of-america-dba-pcca/cfe1029c-d112-4e11-83b8-e258de53a297

> FDA 483 for Professional Compounding Centers of America dba PCCA on April 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Professional Compounding Centers of America dba PCCA
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Professional Compounding Centers of America dba PCCA, an API Repacker/Relabeler in Houston, TX, was cited for three significant observations. These included failures in maintaining appropriate environmental conditions to prevent contamination during repackaging, inadequate transfer of API manufacturer information to customers, and deficiencies in the quality unit's investigation and resolution of critical deviations. The findings indicate serious concerns regarding product quality and safety.

## Related Documents

- [483 - 2019-10-29](https://www.keypedia.com/records/483/professional-compounding-centers-of-america-dba-pcca/7aa00cb1-2468-4b22-af49-2d6a14fbc928)

## Related Officers

- [investigator](https://www.keypedia.com/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)
- [Cameron E. Moore](https://www.keypedia.com/people/cameron-e-moore/5a879539-24b7-4c54-99e4-b8e31f18ec9b)
- [Christopher Tran](https://www.keypedia.com/people/christopher-tran/b56e5f0a-d81e-4759-8acd-2c1dd9bebef2)

Company: https://www.keypedia.com/companies/professional-compounding-centers-of-america-dba-pcca/c1d0b129-067b-42a8-94b9-4e98001fa417

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