# FDA EIR - Garonit Pharmaceutical, Inc. - July 06, 2023

Source: https://www.keypedia.com/records/eir/garonit-pharmaceutical-inc/40f560e8-cb0e-46bb-bff2-9557ac414f4f

> FDA EIR for Garonit Pharmaceutical, Inc. on July 06, 2023. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Garonit Pharmaceutical, Inc.
- Inspection Date: 2023-07-06
- Product Type: veterinary
- Office Name: Food and Drug Administration
- Summary: An FDA surveillance inspection of Garonit Pharmaceutical Inc., an Active Pharmaceutical Ingredients (API) manufacturer of Chlorhexidine Gluconate 20% USP, was conducted from June 27 to July 06, 2023. The inspection adhered to Compliance Programs for Animal Drug Manufacturing and API Process Inspections, as well as ICH Q7 Good Manufacturing Guidance for Active Pharmaceutical Ingredients.

The inspection revealed two main violations, leading to a Form FDA 483. The first, a repeat observation, cited the company's failure to extend investigations to all potentially affected batches. This specifically related to a PCMX contamination incident in a Chlorhexidine Gluconate 20% USP lot, where the investigation, despite tracing the root cause to a raw material supplier's cleaning agent, was not expanded to other API lots manufactured using the same raw material. Additionally, the complaint handling procedure lacked defined timelines for initiating and closing investigations.

The second observation concerned the failure to adequately document and investigate deviations. This included not initiating a deviation or investigation when a batch of Chlorhexidine Gluconate 20% USP was voided due to unexplained overnight weight variability, potentially from a water leak. Furthermore, a deviation report for a prolonged low humidity excursion in a stability chamber, where API lots were stored, remained open without conclusion or documented justification for keeping samples in the affected chamber, contrary to company procedures.

Garonit Pharmaceutical Inc.'s management acknowledged the findings and committed to submitting a written response to the FDA within 15 business days, detailing corrective actions. A verbal discussion also emphasized the need to enhance water sampling procedures to ensure critical sample handling details are comprehensively documented.

## Related Documents

- [483 - 2020-10-20](https://www.keypedia.com/records/483/garonit-pharmaceutical-inc/6a834108-7ef3-4377-a2a9-c2d66e407d92)
- [483 - 2023-07-06](https://www.keypedia.com/records/483/garonit-pharmaceutical-inc/995c75ff-b43f-4748-a440-b71b13da4fb0)

## Related Officers

- [company_representative](https://www.keypedia.com/people/rohit-garg/21dea077-a20d-464f-8752-59268a58bf92)
- [other](https://www.keypedia.com/people/david-mazzarell/223fed21-70aa-4460-853f-4f46bbd2b704)
- [recipient](https://www.keypedia.com/people/frank-berstler/89989cdc-eb7b-4798-98b6-a1d245b2c33b)
- [company_representative](https://www.keypedia.com/people/yesha-kathrani/8c57d3a3-2936-42fd-8ea3-a7ce297f7bda)
- [Investigator](https://www.keypedia.com/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)

Company: https://www.keypedia.com/companies/garonit-pharmaceutical-inc/a1d49be9-6558-4320-a2e9-5cc74fe7d45d

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516