# FDA 483 - Microbac Laboratories, Inc. - January 24, 2025

Source: https://www.globalkeysolutions.net/records/483/microbac-laboratories-inc/ed719ff5-a1c2-41b7-a57e-40249228dc9f

> FDA 483 for Microbac Laboratories, Inc. on January 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microbac Laboratories, Inc.
- Inspection Date: 2025-01-24
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: Microbac Laboratories, Inc. in Sterling, VA, a contract testing laboratory, received a Form 483 citing significant deficiencies in its quality system. The inspection revealed that the firm's investigations into out-of-specification and unexpected results were not thorough or fully documented, lacking conclusions and follow-up. Additionally, the quality control unit failed to ensure complete OOS investigation reports were reviewed and approved, a repeat observation from a previous inspection.

## Related Documents

- [483 - 2021-05-24](https://www.globalkeysolutions.net/records/483/microbac-laboratories-inc/b3087808-061d-41ce-95b0-93ba2e32ff65)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.globalkeysolutions.net/companies/microbac-laboratories-inc/e634e459-2807-4380-8097-9d66cb9d2d29

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa