# FDA WARNING_LETTER - Vista Pharmaceuticals Limited - September 23, 2016

Source: https://www.keypedia.com/records/warning_letter/vista-pharmaceuticals-limited/d770b08f-1c4b-483f-9245-0c1e848114c2

> FDA WARNING_LETTER for Vista Pharmaceuticals Limited on September 23, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vista Pharmaceuticals Limited
- Inspection Date: 2016-09-23
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Vista Pharmaceuticals Limited following a September 19-23, 2016, inspection of their drug manufacturing facility in India, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211). This renders their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include:
1.  **Equipment Maintenance (21 CFR 211.67(a))**: The firm failed to properly clean and maintain equipment. Investigators observed holes and corrosion in equipment used for manufacturing various tablets, including isoxsuprine hydrochloride USP, 20 mg tablets. A prior complaint of metal embedded in tablets was not adequately investigated regarding equipment condition. The firm's response was inadequate for not including a retrospective review of affected products.
2.  **Process Validation (21 CFR 211.100(a))**: The firm admitted to not performing process validation for isoxsuprine hydrochloride USP, 20 mg tablets, despite distributing numerous batches to the U.S. The response was inadequate for not outlining a validation plan or a retrospective risk assessment for distributed batches.

Additionally, the firm's isoxsuprine hydrochloride USP, 20 mg tablets (NDC 61971-065) were deemed

## Related Officers

- [Thomas J. Cosgrove](https://www.keypedia.com/people/thomas-j-cosgrove/616abec3-5ed9-42aa-9f5d-392b5552b695)
- [Retired-FDA Compliance Officer, CDER](https://www.keypedia.com/people/carla-a-norris/90f059dd-f4cc-4599-b9c9-134465185c49)

Company: https://www.keypedia.com/companies/vista-pharmaceuticals-limited/fd49c6f3-f743-40ef-9967-33f70e3b791b

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c