# FDA 483 - Waterlab Corporation - July 30, 2021

Source: https://www.keypedia.com/records/483/waterlab-corporation/efc35372-d8b3-4c03-bc73-8f2b560c3777

> FDA 483 for Waterlab Corporation on July 30, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Waterlab Corporation
- Inspection Date: 2021-07-30
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Waterlab Corporation, a contract testing laboratory in Salem, OR, was cited for significant deficiencies in its laboratory operations. Observations included inadequate verification of testing methods for pharmaceutical-grade water, insufficient quality assurance review of laboratory records, and a lack of scientifically sound test procedures. Additionally, the firm failed to calibrate instruments at suitable intervals and allowed an untrained analyst to perform critical testing, compromising the integrity of over 200 reported test results.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/waterlab-corporation/eed447aa-4d92-4aae-86a3-c6ab2f506397

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