# FDA 483 - Pensacola Apothecary, Inc.  DBA Everwell Specialty Pharmacy - August 31, 2016

Source: https://www.keypedia.com/records/483/pensacola-apothecary-inc-dba-everwell-specialty-pharmacy/547f46d9-db15-46ee-8c7c-e4397c483fb4

> FDA 483 for Pensacola Apothecary, Inc.  DBA Everwell Specialty Pharmacy on August 31, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pensacola Apothecary, Inc.  DBA Everwell Specialty Pharmacy
- Inspection Date: 2016-08-31
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: On August 22-26, 29, 31, 2016, the FDA inspected Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy, FEI 3005630265, located at 6506 N. Davis Highway, Pensacola, FL 32504. The firm produces sterile and non-sterile drug products. The inspection resulted in four observations.

Observation 1 noted improper gowning apparel storage, specifically gowns for aseptic production stored near a sink in the anteroom, risking contamination from splashes during handwashing.

Observation 2 identified a failure to disinfect equipment, materials, and/or supplies before entering aseptic processing areas. During the production of Methylcobalamin Lot 08242016@10, the inside surface of the ISO5 unit was not sanitized prior to use, despite SOP 5.2.1 requiring cleaning of aseptic production work surfaces.

Observation 3 cited the lack of written procedures for cleaning and maintenance of equipment and utensils used in drug product manufacturing. The Cleaning And Maintenance of the Non-Sterile Compounding Area SOP 4.15 has not been validated to ensure removal of residual product and sanitizing agents, and to prevent cross-contamination between batches.

Observation 4 indicated the absence of written production and process controls to assure drug product identity, strength, quality, and purity. Specifically, mixing instructions, such as

## Related Documents

- [483_RESPONSE - 2016-08-31](https://www.keypedia.com/records/483_response/pensacola-apothecary-inc-dba-everwell-specialty-pharmacy/dec71235-e5f8-4480-8683-fc441184d9bc)
- [WARNING_LETTER - 2016-08-31](https://www.keypedia.com/records/warning_letter/pensacola-apothecary-inc-dba-everwell-specialty-pharmacy/e51af199-f105-4326-89c1-b0cb7c238dec)
- [OTHER_CORRESPONDENCE - 2018-08-02](https://www.keypedia.com/records/other_correspondence/pensacola-apothecary-inc-dba-everwell-specialty-pharmacy/19d86f7f-af7a-4662-a3ac-eb535fbe45fb)

## Related Officers

- [Investigator](https://www.keypedia.com/people/joshua-p-wireman/1f5cca58-4a35-4b1a-b344-35820b1e58fb)

Company: https://www.keypedia.com/companies/pensacola-apothecary-inc-dba-everwell-specialty-pharmacy/245f5b01-930e-4a49-932e-3533eacccc4e

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