# FDA 483 - coast quality pharmacy, llc  - May 07, 2018

Source: https://www.keypedia.com/records/483/coast-quality-pharmacy-llc/100d81ce-9ff3-48f0-a856-1c66de88e890

> FDA 483 for coast quality pharmacy, llc  on May 07, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: coast quality pharmacy, llc 
- Inspection Date: 2018-05-07
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: The FDA Form 483 details numerous violations at a facility producing radiopharmaceuticals like In-111-DTPA. A critical finding is the use of non-pharmaceutical grade In-111 and DTPA, lacking testing for microorganisms and endotoxins. The facility also fails to test In-111 for chemical impurities, radiochemical purity, radionuclide purity, microorganisms, yeasts, mold, and endotoxins.

Significant quality system and manufacturing issues include poor aseptic techniques: returning withdrawn material to stock vials, using non-sterile wipes in ISO 5 areas, and improper disinfection of equipment. Environmental monitoring revealed objectionable organisms (Coagulase-negative Staphylococcus, fungi, Bacillus spp.) in ISO 7 and ISO 8 rooms without documented corrective actions. Smoke studies under dynamic conditions are lacking, and unidirectional laminar airflow is not demonstrated.

The facility uses non-representative samples for endotoxin testing (syringe rinses instead of finished product). Equipment like lyophilizers are not validated, leading to product being stuck in cycles. De-crimped, commercially sterile vials are stored improperly in ISO 7 conditions without documentation of storage time.

Repeated deficiencies from a previous inspection include:
- Lack of daily surface and air monitoring in ISO-5 LAFWs.
- No daily personnel monitoring (fingertip sampling).
- Unassessed suitability and efficacy of disinfecting agents.
- Lack of written procedures for component receipt, identification, storage, handling, sampling, testing

## Related Documents

- [483 - 2019-05-09](https://www.keypedia.com/records/483/coast-quality-pharmacy-llc/004f84c1-699e-419a-9c2b-feaa8211920c)

## Related Officers

- [Senior Portfolio Manager](https://www.keypedia.com/people/christie-soto/34bb6690-bb58-4742-ab52-5e4fea9d6262)
- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/coast-quality-pharmacy-llc/51426e9d-9637-4ecf-9e5e-49c30c3f9e67

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