# FDA 483 - Brooks Life Sciences Inc - July 06, 2018

Source: https://www.keypedia.com/records/483/brooks-life-sciences-inc/c1cdacf8-84cb-4cda-b895-5580225d12b2

> FDA 483 for Brooks Life Sciences Inc on July 06, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brooks Life Sciences Inc
- Inspection Date: 2018-07-06
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of BioStorage Technologies in Indianapolis, IN, an HCT/P establishment, identified one observation. The firm failed to maintain equipment used for manufacturing HCT/Ps according to established schedules. Specifically, a cryogenic freezer used for human tissue storage was not maintained per the manufacturer's manual.

## Related Officers

- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.keypedia.com/companies/brooks-life-sciences-inc/5bffdb19-aee2-4119-840b-ce3e560f0ef0

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0