# FDA 483 - Aldrich Chemical - December 13, 2021

Source: https://www.keypedia.com/records/483/aldrich-chemical/bdf57a8d-85ef-49da-9730-28b15c53943b

> FDA 483 for Aldrich Chemical on December 13, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aldrich Chemical
- Inspection Date: 2021-12-13
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Aldrich Chemical Co, LLC, an API manufacturer in Miamisburg, OH, was cited for significant deficiencies during an FDA inspection. The inspection revealed inadequate investigations into out-of-specification results and deviations, along with serious data integrity issues related to computerized systems and raw data review. Additional concerns included a lack of equipment use logs, insufficient environmental monitoring in GMP production areas, and improper employee gowning.

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)

Company: https://www.keypedia.com/companies/aldrich-chemical/952e715f-08fa-455a-a0ae-f640e6a24704

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22