# FDA 483 - Pyramid Laboratories, Inc. - April 11, 2019

Source: https://www.keypedia.com/records/483/pyramid-laboratories-inc/0bb4aff3-e571-4a35-aa5a-c0a070eee8ee

> FDA 483 for Pyramid Laboratories, Inc. on April 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pyramid Laboratories, Inc.
- Inspection Date: 2019-04-11
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Pyramid Laboratories, Inc. in Costa Mesa, CA, a sterile drug manufacturer and contract test laboratory, revealed significant deficiencies in their laboratory control systems. The firm failed to adequately quantitate and evaluate impurity levels for G-Pen Glucagon Injection 5 mg/mL. This included a lack of appropriate release specifications for impurities and insufficient validation of the test method used for impurity content.

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## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [investigator](https://www.keypedia.com/people/amanda-l-fyles/4a00278a-a7c5-4751-a8b7-6c0ce2e24272)
- [Investigator](https://www.keypedia.com/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)

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