# FDA 483 - Synergy Pharmacy Services, Inc. - June 21, 2016

Source: https://www.keypedia.com/records/483/synergy-pharmacy-services-inc/09cafc72-69e8-42f0-9d6f-7b5aa93a5691

> FDA 483 for Synergy Pharmacy Services, Inc. on June 21, 2016. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Synergy Pharmacy Services, Inc.
- Inspection Date: 2016-06-21
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: The FDA Form 483 details significant deficiencies in aseptic processing and quality control at a facility producing sterile drug products, specifically Glutathione Sterile Inhalation solution.

Key violations include:
- **Inadequate Media Fills:** Media fills used for technician qualification do not simulate current processes, lack challenging conditions, and deviate from Policy # RV-IV-18. Deficiencies include incorrect media fill process simulation, absence of growth promotion tests, undocumented incubator use, and lack of comprehensive media fill documentation.
- **Contamination Control Issues:** Lab coats identified as single-use are re-used and received in non-sealed bags, indicating non-sterility. Sterile coveralls are not required or observed in the ISO 5 area.
- **Insufficient Personnel Monitoring:** No documented fingertip sampling after media fills or production batches, and no procedure requiring it.
- **Environmental Monitoring Deficiencies:** No continuous or periodical monitoring of air pressure differentials, relative humidity, or temperature during operations in ISO 5 and ISO 7 areas. Viable and non-viable monitoring is not performed or required in the ISO 5 area during production, nor is surface monitoring on the curtain between ISO 5 and 7 areas. Acceptance criteria are not justified.
- **Air Supply and Filtration Issues:** Policy RX-IV-13 lacks acceptance criteria for ISO 5 and ISO 7 cleanroom certification, does not require review of contractor certification packages, or documentation of static/dynamic conditions.

## Related Officers

- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

Company: https://www.keypedia.com/companies/synergy-pharmacy-services-inc/10b65c6a-83ab-4de8-adde-377327f42a17

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