# FDA 483 - Biotest Pharmaceuticals Corporation - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/biotest-pharmaceuticals-corporation/aa3bfe50-f0e4-4a48-80cc-05c54e063ca6

> FDA 483 for Biotest Pharmaceuticals Corporation on Unknown Date. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biotest Pharmaceuticals Corporation
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Biotest Pharmaceuticals Corporation's plasmapheresis center in Hinesville, Georgia, revealed significant deficiencies in donor qualification and record-keeping. The firm failed to consistently perform required serologic tests for syphilis and serum protein electrophoresis on initial donor samples, leading to the collection of unsuitable plasma units. Additionally, discrepancies were found in manufacturing records regarding the lot numbers of supplies used for plasma collections, raising concerns about product traceability and data integrity.

## Related Officers

- [Investigator at U.S.FDA](https://www.globalkeysolutions.net/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)
- [Barbara G. Peoples](https://www.globalkeysolutions.net/people/barbara-g-peoples/43dd2619-3f3b-4bb2-b4ad-c522f3c31225)

Company: https://www.globalkeysolutions.net/companies/biotest-pharmaceuticals-corporation/6c446127-1005-4209-ac3e-dccfbd5fbb3b

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