# FDA 483 - lincare, inc.  - August 22, 2017

Source: https://www.keypedia.com/records/483/lincare-inc/834582b1-bdbf-4e82-aa82-66e38acf53d4

> FDA 483 for lincare, inc.  on August 22, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: lincare, inc. 
- Inspection Date: 2017-08-22
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: On August 22, 2017, the FDA issued a Form 483 to Lincare, Inc. dba United Medical Home Infusion, located at 1527 South Bowman Road Suite D, Little Rock, AR 72211-4200. The inspection, conducted by Investigator Jason R. Caballero, took place from August 14-22, 2017. The facility is identified as a producer of sterile drug products.

The sole observation noted during the inspection was:

**Observation 1:** A disinfecting agent used in the ISO 5 areas is not sterile. Specifically, the firm utilizes a non-sterile disinfectant in the ISO 5 areas, which is applied on a regular basis in the firm's laminar airflow hoods.

This observation indicates a potential quality system and manufacturing issue related to maintaining aseptic conditions in critical sterile processing environments. The use of a non-sterile disinfectant in ISO 5 areas, which are designed for sterile operations, could compromise the sterility of drug products produced. The document does not specify any regulatory citations but highlights a deficiency in the firm's control over its sterile manufacturing environment.

## Related Documents

- [483 - 2015-06-12](https://www.keypedia.com/records/483/lincare-inc/72ecd0ae-1ab0-4381-8e83-8732112ba4f1)
- [483 - 2017-08-22](https://www.keypedia.com/records/483/lincare-inc/29b02f4d-3534-4a88-830d-ad0e4bf5a9b3)
- [STATE_REFERRAL_LETTER - 2017-03-20](https://www.keypedia.com/records/state_referral_letter/lincare-inc/29b83c18-11ef-42ef-bced-018c20e940ad)

## Related Officers

- [Jason R. Caballero](https://www.keypedia.com/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)

Company: https://www.keypedia.com/companies/lincare-inc/d863215a-4274-4407-ba82-176c40810e4a

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9