# FDA 483 - lincare, inc.  - June 12, 2015

Source: https://www.keypedia.com/records/483/lincare-inc/72ecd0ae-1ab0-4381-8e83-8732112ba4f1

> FDA 483 for lincare, inc.  on June 12, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: lincare, inc. 
- Inspection Date: 2015-06-12
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 inspection revealed significant deficiencies in aseptic processing, environmental monitoring, and facility control. The ISO 8 Ante Room was out of certification from April 9, 2015, yet approximately (b)(4) sterile products were produced in ISO 7 Buffer Rooms at ISO 5 Hoods between April 9 and May 29, 2015. Pressure differentials were consistently out of acceptable range, with the ISO 7 Hazard Room showing "0" pressure from January 2, 2014, to May 29, 2015, despite a required minimum of -(b)(4) inches of water. Pressure gauges for critical room differentials were not calibrated, nor was the incubator for environmental monitoring samples.

Facility issues included a difficult-to-clean, damaged chair in an ISO 7 Buffer Room, an ISO 5 hood on a wooden table, and corroded, difficult-to-clean ISO 5 hoods. Personnel gowning was inadequate, with technicians observed wearing non-sterile attire and exposing skin, and cleaning practices were deficient, including touching contaminated surfaces and re-entering clean areas without sanitizing gloves. Unsanitized items were brought into the ISO 8 area, and reusable cleaning tools were moved between rooms without sanitization.

Pest infestations were observed in the ISO 8 area, including a live worm-like pest, a live spider, and dead insects in a refrigerator holding

## Related Documents

- [483 - 2017-08-22](https://www.keypedia.com/records/483/lincare-inc/834582b1-bdbf-4e82-aa82-66e38acf53d4)
- [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

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)
- [Investigator](https://www.keypedia.com/people/shelby-n-marler/2cbb1b1c-ad36-4385-b61f-bee80ad8e1bd)
- [Investigator](https://www.keypedia.com/people/matthew-r-maddox/4066b967-2ceb-46e2-9276-f96436f87fb7)

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