# FDA 483 - Pyramid Laboratories, Inc. - September 29, 2021

Source: https://www.keypedia.com/records/483/pyramid-laboratories-inc/a7da19b8-1ff7-468d-9d46-7c0a36476b3a

> FDA 483 for Pyramid Laboratories, Inc. on September 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pyramid Laboratories, Inc.
- Inspection Date: 2021-09-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pyramid Laboratories, Inc. in Costa Mesa, CA, received a Form 483 with five observations during an FDA inspection. The findings highlight significant deficiencies in quality control, including inadequate sampling plans, environmental monitoring, laboratory instrument calibration, and data integrity controls for computer systems. These issues indicate a moderate level of non-compliance with good manufacturing practices.

## Related Documents

- [483 - 2015-01-15](https://www.keypedia.com/records/483/pyramid-laboratories-inc/5047c005-f28b-4bc8-a75f-b4432491ed90)
- [483 - 2019-04-11](https://www.keypedia.com/records/483/pyramid-laboratories-inc/0bb4aff3-e571-4a35-aa5a-c0a070eee8ee)
- [483 - Unknown Date](https://www.keypedia.com/records/483/pyramid-laboratories-inc/dc25f79a-2ac2-4cd6-be5d-55d31ee5aee7)
- [EIR - 2021-09-29](https://www.keypedia.com/records/eir/pyramid-laboratories-inc/3b4cd563-39c6-48e7-b9d3-50b14d7187ec)

## Related Officers

- [Claudia Perez-Kass](https://www.keypedia.com/people/claudia-perez-kass/1e36fc79-1300-4a3b-b90e-ce1d3ec84670)
- [Miguel A. Martinez](https://www.keypedia.com/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)
- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)
- [investigator](https://www.keypedia.com/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6