# FDA 483 - Dynalabs LLC - October 29, 2012

Source: https://www.keypedia.com/records/483/dynalabs-llc/58279535-db6a-49e3-9a5b-9a3909f2a97c

> FDA 483 for Dynalabs LLC on October 29, 2012. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dynalabs LLC
- Inspection Date: 2012-10-29
- Office Name: Kansas City District Office
- Summary: The FDA Form 483 details significant deficiencies in a facility's quality control and manufacturing processes.

**Sterility Testing and Procedures:**
*   The firm issues Certificates of Analysis (CoAs) citing USP <71> for sterility testing but does not follow its requirements for the number of articles to be tested based on batch size.
*   Batch size information is not required from clients, nor is there documentation to ensure clients submit the correct number of articles for initial or re-testing.
*   Specifically, for drug product glutathione/vitamin C/DMOS, lot (b)(4), the required number of articles per USP <71> was not submitted for testing or re-testing.
*   Procedure MIC-SOP-0016 for re-testing is inadequate, lacking definitions for "proven lab error" and documentation requirements for invalidation and re-testing of initial out-of-specification (OOS) results.

**Laboratory Controls and Potency Analysis:**
*   No written procedure exists for potency analysis of methylprednisolone.
*   Sample calculations for potency analysis lack descriptions in analytical worksheets or written procedures, including drug product bug volume corrections. This was observed in multiple investigation reports for various drug products.
*   Sample preparation descriptions in test schedules are insufficient, lacking details on sample handling, equipment type (e.g., autopipette), glassware, and protection from degradation (e.g., for methylpred

## Related Documents

- [483 - 2019-09-26](https://www.keypedia.com/records/483/dynalabs-llc/c42e6665-fe90-4922-8d79-4bb2c5e417a9)
- [483 - 2019-09-26](https://www.keypedia.com/records/483/dynalabs-llc/b0e4d9df-b27e-46a6-8fa6-0b2cc0582ee2)

## Related Officers

- [Associate Vice President](https://www.keypedia.com/people/kallal-biswas/9791fb98-0764-4c9c-a14b-80bc6c2015cf)
- [R&D](https://www.keypedia.com/people/matthew-hunt/9a6aa10d-2ac3-423e-a10f-efca656bb01b)
- [Senior Consultant](https://www.keypedia.com/people/steven-d-kehoe/a080151a-e2eb-436d-95b1-950bde664288)
- [Project Director](https://www.keypedia.com/people/eric-m-padgett/a42150bc-aa7f-4076-8a68-af47ff465bac)

Company: https://www.keypedia.com/companies/dynalabs-llc/587bc1ff-dada-4c06-8730-e936ed98ab03

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79