# FDA 483 - Advanced Pharma Inc. - July 22, 2016

Source: https://www.keypedia.com/records/483/advanced-pharma-inc/1c1b827a-e422-4ac6-b65d-b009e4094dd8

> FDA 483 for Advanced Pharma Inc. on July 22, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Pharma Inc.
- Inspection Date: 2016-07-22
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 documents observations from an inspection of a facility producing sterile drug products. Key deficiencies include the lack of established procedures to prevent microbiological contamination of sterile drug products. Specifically, non-sterile and sterile sanitizers are used for ISO 5 Laminar Air Flow hoods, but the non-sterile sanitizer is not sterilized prior to use, and there is no data to support its sporicidal efficacy.

Media fill process simulations are not conducted under challenging conditions, with a significant portion of the media fill consisting of a single unit type. The firm produced a large lot of Phenylephrine 100mcg/ml in Normal Saline in Syringes (lot #4/22/16 1310 830-61(s)) totaling (b)(4) units.

Test procedures for sterility and pyrogens are not written, and endotoxin testing is not performed for epidural drug products such as Fentanyl (2mcg/ml) and 0.125% Bupivacaine HCl PF in 150ml Bag (lot #6/27/16 1021 21915P) and Morphine Sulfate PF 1mg/ml in 2ml vial (lot #6/29/16 1045 24142EPF), which were distributed.

Suitability testing has not been

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Company: https://www.keypedia.com/companies/advanced-pharma-inc/2c95199b-337b-49f2-9c75-e96c62ff2853

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9