# FDA 483 - Pyramid Laboratories, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/pyramid-laboratories-inc/dc25f79a-2ac2-4cd6-be5d-55d31ee5aee7

> FDA 483 for Pyramid Laboratories, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pyramid Laboratories, Inc.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Pyramid Laboratories, Inc. in Costa Mesa, CA, was inspected from January 28 to February 3, 2021, and received one observation. The inspection revealed failures in following aseptic techniques and procedures designed to prevent microbiological contamination during the manufacture of sterile drug products. This indicates a significant risk to product sterility and quality.

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- [483 - 2019-04-11](https://www.keypedia.com/records/483/pyramid-laboratories-inc/0bb4aff3-e571-4a35-aa5a-c0a070eee8ee)
- [EIR - 2021-09-29](https://www.keypedia.com/records/eir/pyramid-laboratories-inc/3b4cd563-39c6-48e7-b9d3-50b14d7187ec)
- [483 - 2021-09-29](https://www.keypedia.com/records/483/pyramid-laboratories-inc/a7da19b8-1ff7-468d-9d46-7c0a36476b3a)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/pyramid-laboratories-inc/28e777be-a530-400a-97c6-9780ede4fb33

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd