# FDA 483 - Viatris Inc. - April 12, 2018

Source: https://www.keypedia.com/records/483/viatris-inc/24a2a7cc-647e-427c-9f53-a9a19e40ec12

> FDA 483 for Viatris Inc. on April 12, 2018. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Viatris Inc.
- Inspection Date: 2018-04-12
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: This FDA Form 483 details observations from an inspection of Mylan Pharmaceuticals Inc., a finished drug product manufacturer located at 781 Chestnut Ridge Rd, Morgantown, WV, conducted from March 19, 2018, to April 12, 2018.

**Key Observations:**

1.  **Quality Unit Deficiencies:** The Quality Unit (QU) failed to fully follow its procedures, lacking appropriate oversight in approving change controls and reviewing/approving equipment and facilities.
2.  **Process Control Issues (Metolazone 2.5 mg Tablets):** Inadequate process control parameters led to Out-of-Tolerance/Out-of-Specification (OOT/OOS) content uniformity results for Metolazone 2.5 mg Tablets, with multiple Manufacturing Investigation Reports (MIRs) opened and one batch rejected. Corrective and preventive actions (CAPAs) failed to mitigate powder segregation and content uniformity issues.
3.  **Unapproved Changes (Doxycycline Hyclate Delayed-release Tablets):** The QU implemented changes to weight and hardness specifications for Doxycycline Hyclate Delayed-release Tablets without adequate evaluation or accelerated stability studies, leading to dissolution profile issues during long-term stability.
4.  **Inadequate Cleaning Procedures and Investigation Scope:** Root cause for contamination was identified as inadequate cleaning procedures (MPI-SOP-MFG-ENC-0008) and

## Related Documents

- [483 - 2016-11-18](https://www.keypedia.com/records/483/viatris-inc/afa3589b-bae0-4641-aa0e-5f252d238128)
- [483 - 2019-07-25](https://www.keypedia.com/records/483/viatris-inc/5ad9b2c3-4f0d-434b-9011-3fcc0d10111e)
- [483 - 2019-08-15](https://www.keypedia.com/records/483/viatris-inc/9e200adb-c8fe-45a3-bf9b-b1fdcc0a6b7d)
- [483 - 2022-05-26](https://www.keypedia.com/records/483/viatris-inc/8ba662c8-1553-4929-bc10-4fe7831bbf9c)
- [WARNING_LETTER - 2024-06-26](https://www.keypedia.com/records/warning_letter/viatris-inc/486d0c63-dd02-4bd9-a54c-75405be98540)

## Related Officers

- [Rebecca E. Dombrowski](https://www.keypedia.com/people/rebecca-e-dombrowski/2979b9b1-d067-4165-a5c2-5f0b94dd4eaf)
- [Regulatory Counsel at FDA with a PharmD and JD](https://www.keypedia.com/people/melissa-t-roy/4aa8cad9-af71-45fd-a2c9-326a06f754c9)
- [Vice President, Technical](https://www.keypedia.com/people/leana-barreto-pettit/51dfd8a1-88d7-4d73-b3d4-85d33bcdf923)
- [Regulatory Affairs](https://www.keypedia.com/people/atul-j-agrawal/7c9fab5d-a13f-4217-a6fc-9dfc0bbbd555)
- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.keypedia.com/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)

Company: https://www.keypedia.com/companies/viatris-inc/e65d242e-4279-4e07-992f-5f241792c2cf

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