# FDA 483 - Sarepta Therapeutics Inc - March 24, 2023

Source: https://www.globalkeysolutions.net/records/483/sarepta-therapeutics-inc/bca73744-787b-49ec-99bb-17925f689f5a

> FDA 483 for Sarepta Therapeutics Inc on March 24, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sarepta Therapeutics Inc
- Inspection Date: 2023-03-24
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Sarepta Therapeutics, Inc.'s biological drug testing lab in Andover, MA, revealed significant deficiencies in its quality control unit. The firm failed to timely investigate errors related to drug product stability, reference material, and release testing, leaving multiple quality events unresolved. Additionally, there was no written procedure for trending method failures, and a critical potency method exhibited a high failure rate.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sukyoung-sohn/f3ab72eb-f212-4603-9625-c5740cf56980)
- [investigator](https://www.globalkeysolutions.net/people/emmanuel-adu-gyamfi/50f014f0-f8d5-4b21-9cb0-0fdcf785edb5)
- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)

Company: https://www.globalkeysolutions.net/companies/sarepta-therapeutics-inc/5a8d2168-ec04-4530-a81f-00bab06c4a44

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7