# FDA 483 - SaveWay Compounding Pharmacy, Inc. - June 29, 2017

Source: https://www.keypedia.com/records/483/saveway-compounding-pharmacy-inc/75946c5d-4010-4674-9b27-4f1460bd1226

> FDA 483 for SaveWay Compounding Pharmacy, Inc. on June 29, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SaveWay Compounding Pharmacy, Inc.
- Inspection Date: 2017-06-29
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: This FDA Form 483 document details observations made during an inspection of SaveWay Compounding Pharmacy, Inc., located at 31 Albe Drive Suite 1, Newark, DE 19702-1360. The inspection, conducted by Investigator Anita R Michael, took place from June 13, 2017, to June 29, 2017. The firm is identified as a producer of sterile and non-sterile drug products. The inspection was issued to Pradeep Chilakapati, Staff Pharmacist.

The sole observation noted is a deficiency in aseptic processing areas regarding the system for monitoring environmental conditions. Specifically, pressure differentials between the ISO 7 room and ISO 8 room, which have different air classifications, were not monitored prior to or during sterile drug production. This is explicitly noted as a repeat observation, indicating a previously identified and uncorrected issue. The FEI Number for the facility is 3006101483.

## Related Documents

- [483 - 2015-10-02](https://www.keypedia.com/records/483/saveway-compounding-pharmacy-inc/bf2bd839-2148-45d6-b10e-a9ca3ac2ff51)

## Related Officers

- [Investigator](https://www.keypedia.com/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)

Company: https://www.keypedia.com/companies/saveway-compounding-pharmacy-inc/100f3332-689c-4c8c-b1c3-d1bb280ef860

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8