# FDA 483 - franck's lab inc  - May 23, 2014

Source: https://www.keypedia.com/records/483/francks-lab-inc/d7a35c49-5f6f-4fbc-b18c-b9f656c3f7c8

> FDA 483 for franck's lab inc  on May 23, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: franck's lab inc 
- Inspection Date: 2014-05-23
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: The FDA inspection of a drug manufacturing facility revealed multiple deficiencies across its aseptic processing areas and quality systems. The facility's ISO 7 clean room and ISO 8 ante-room had unsealed ceiling tiles, visible tears in two ISO 7 ceiling tiles (one porous), and walls that were not smooth or easily cleanable. Flaking paint and rust were observed on an ISO-5 laminar flow hood bench. The impact of ongoing remodeling on ISO 7 clean room airflow was not assessed, nor was a risk assessment performed for potential product contamination.

The ISO 7 clean room contained inappropriate items like a radio, computer monitor, cardboard boxes, and a piece of wood. Dead insects were found on light panels above the ISO 5 laminar flow hood and the ante-room. Procedures to prevent microbiological contamination were not established. A pharmacy technician handled elastomeric infusion devices with bare hands before hand washing/gowning and without sanitization. These devices were later transferred to the ISO-5 processing bench without a sanitization step. Compounding instructions for Vancomycin were incomplete, lacking proper aseptic technique.

Cleaning and disinfecting procedures were deficient. ISO 5 surfaces were cleaned only with one solution, lacking a cleanser or sporicidal disinfectant. Conflicting written work instructions existed for sanitizers. A disinfectant bottle in use was over one year past its expiration date. Laminar flow hoods were relocated, potentially obstructing airflow, and the ISO 7 clean room was not qualified under these new conditions.

## Related Officers

- [Investigator](https://www.keypedia.com/people/lesley-satterwhite/030978c6-daaa-42e9-bf63-f90a5647f0f0)
- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Vascular Neurologist Investigator](https://www.keypedia.com/people/sean-d-duke/ea627ffa-8e7c-4c2e-a9e0-31a41fe44ccf)

Company: https://www.keypedia.com/companies/francks-lab-inc/890c0505-30e4-47c2-9c7c-72178de72f2b

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9