# FDA 483 - Purisys LLC - March 13, 2024

Source: https://www.keypedia.com/records/483/purisys-llc/f5d819be-0148-4cd7-9d8d-0f13f4e8f7b6

> FDA 483 for Purisys LLC on March 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Purisys LLC
- Inspection Date: 2024-03-13
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: During an FDA inspection conducted from March 11-13, 2024, Purisys LLC, an API and Intermediate Manufacturer, received several significant observations regarding its operational and facility conditions.

The primary concern, Observation 1, highlighted that buildings used for manufacturing, processing, packing, or holding drug products were not maintained in a clean and sanitary state, nor were they free from infestation. Specific issues noted included discoloration, appearing microbiological in nature, around a sprinkler cover in the Small Scale Production Facility (SSPF) Suite, which is used for commercial API and intermediate manufacturing. Investigators also observed flies within a covered ceiling light in the SSPF's Hood, a critical area containing filter dryers and a phase separation vessel. Furthermore, raw materials stored in the loading dock were in an unclean area with apparent bird droppings and dirty drum lids. The Stability Room, also used for GMP raw material storage, contained a spider web with two spiders. An exposed, uncleansed drainage system with what appeared to be a roach was found in a Storage Room adjacent to the Stability Room and near processing suites.

Observation 2 indicated a deficiency in the company's written procedures concerning the handling of drug product containers. Specifically, a procedure governing material and personnel movement in the SSPF failed to adequately detail the cleaning process for raw material containers that are exposed to the environment in the facility's loading dock, where dirty drum lids were also noted.

These observations require Purisys LLC to implement comprehensive corrective actions to ensure compliance with good manufacturing practices and maintain product quality and safety.

## Related Documents

- [483 - 2024-03-13](https://www.keypedia.com/records/483/purisys-llc/c79c1f11-c5cc-42fd-9180-7349960c90d9)

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.keypedia.com/companies/purisys-llc/1cf69929-9d86-4fb5-b06c-a5533522ecd5

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