# FDA 483 - ModernaTX, Inc. - September 21, 2023

Source: https://www.keypedia.com/records/483/modernatx-inc/1583f95f-f001-42f8-b300-875d5e40759c

> FDA 483 for ModernaTX, Inc. on September 21, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ModernaTX, Inc.
- Inspection Date: 2023-09-21
- Product Type: Drugs
- Office Name: New England District Office
- Summary: The FDA Form 483 details multiple deficiencies at a drug substance manufacturing facility, specifically concerning mRNA-1273.

**Key Violations and Observations:**

1.  **Improper Equipment Cleaning:** Equipment for drug substance manufacturing, including ID# MIX-1805, MIX-7807, MIX-7805, MIX-3807, and MIX-3807, was not properly cleaned. SOP-0417, version 10 through 16.0, allowed equipment release without confirming bioburden and endotoxin cleaning verification results. Bioburden failures were identified on samples from these mixers, which were used for released drug substance batches (e.g., 5007522046, 5007522047).

2.  **Deficient Cleaning Validation Studies:** Cleaning Validation studies (VAL-PRO-6414) for non-dedicated equipment did not include challenges with actual manufacturing conditions. "Mock" mixing processes used significantly less time and drug substance volume than routine operations for equipment like MIX-1805, MIX-1807, MIX-7807, MIX-7805, MIX-3807, MIX-3805, MIX-9805, MIX-8805, CRM-1413, CRM-3413

## Related Documents

- [483 - 2023-09-21](https://www.keypedia.com/records/483/modernatx-inc/551e32ae-9508-4418-83f1-039c4a3499e5)

## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Product Specialist ](https://www.keypedia.com/people/swati-verma/4ef6b918-6193-4ef8-96e6-270a7f837deb)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)
- [Regulatory Counsel ](https://www.keypedia.com/people/ben-firschein/fe0ccdcd-4a91-401a-b01a-d15db8a8a04d)

Company: https://www.keypedia.com/companies/modernatx-inc/8d0092a3-f330-4ddf-ae1f-f4dd9c0aba6e

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144