# FDA 483 - Westlab Pharmacy, Inc. dba Westlab Pharmacy - August 15, 2018

Source: https://www.keypedia.com/records/483/westlab-pharmacy-inc-dba-westlab-pharmacy/40379065-37bf-432a-9bc2-660e62cd85a2

> FDA 483 for Westlab Pharmacy, Inc. dba Westlab Pharmacy on August 15, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Westlab Pharmacy, Inc. dba Westlab Pharmacy
- Inspection Date: 2018-08-15
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: The FDA Form 483 details multiple observations from an inspection. The facility's ISO 5 classified aseptic processing area, used for mitomycin and cyclosporine drug products (e.g., Mitomycin Oph 0.02% Lot 06152018@13, Cyclosporin Aqueous 0.5% solution Lot 06132018@43), was located within a non-classified room. Non-sterile disinfecting agents and cleaning wipes were used in ISO 5 areas; specifically, non-sterile wipes were used to clean the ISO 5 Laminar Airflow Workstation (LAFW) prior to a media fill on 08/06/18, and non-sterile products like (b)(4) were used for cleaning.

Non-pharmaceutical grade components were used in drug product formulations, including (b)(4) in Alprostadil 500mcg/mL injectable (Lots 03182018@42, 07252018@17), and in non-sterile products such as Vancomycin/Water 250mg/mL solution (Lot 07022018@53). Personnel engaged in aseptic processing were observed with exposed hands, specifically an operator donning sterile gloves inside the ISO 5 LAFW. The ISO 5 LAFW had difficult-

## Related Documents

- [483 - 2018-08-15](https://www.keypedia.com/records/483/westlab-pharmacy-inc-dba-westlab-pharmacy/a3fda6d9-f760-415c-bd86-3dc765a39d60)
- [WARNING_LETTER - 2018-08-15](https://www.keypedia.com/records/warning_letter/westlab-pharmacy-inc-dba-westlab-pharmacy/bf2d5989-34a0-4a44-afd2-da8a05eb0d95)
- [483 - 2021-10-05](https://www.keypedia.com/records/483/westlab-pharmacy-inc-dba-westlab-pharmacy/b3d4a7b1-1326-4ca9-a8b9-eb7cf3d8bcc6)

## Related Officers

- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/westlab-pharmacy-inc-dba-westlab-pharmacy/54a30fa8-0e3c-4b95-bc83-a302a8d7f885

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