# FDA 483 - Olympia Pharmaceuticals - April 13, 2018

Source: https://www.keypedia.com/records/483/olympia-pharmaceuticals/1487fd2e-82c2-4bc6-9e11-e16dfee15d39

> FDA 483 for Olympia Pharmaceuticals on April 13, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olympia Pharmaceuticals
- Inspection Date: 2018-04-13
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 details observations from an inspection of OPS International Incorporated D/B/A Olympia Pharmacy, an outsourcing facility located at 6700 Conroy Rd Ste 155, Orlando, FL, conducted from April 6-13, 2018. The inspection identified ten observations related to quality systems, manufacturing practices, and product reporting/labeling.

Key violations include:
1.  **Protective Apparel:** Technicians were observed with exposed skin in ISO 5 areas and improperly gowned in ISO 7 areas, failing to protect drug products from contamination.
2.  **Quality Control Unit:** Responsibilities and procedures for the quality control unit were not in writing and fully followed.
3.  **Aseptic Processing Area Cleaning:** Cleaning procedures lacked documentation of contact times for disinfectants, and a hand sanitizer used on sterile gloves lacked scientific data supporting its effectiveness as a disinfectant for cleanroom use.
4.  **Drug Product Release Testing:** No reconstitution specifications were established for lyophilized sterile drug products (e.g., HCG, Sermorelin) prior to release.
5.  **Microbiological Contamination Prevention:** A pharmacy technician touched a door between ISO 8 and ISO 7 rooms without re-sanitizing sterile gloved hands during compounding.
6.  **Environmental Monitoring:** Differential pressure readings were not recorded during sterile drug product compounding, failing to show no excursions.

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## Related Officers

- [Microbiologist](https://www.keypedia.com/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

Company: https://www.keypedia.com/companies/olympia-pharmaceuticals/add75b76-fde6-4e96-8a20-5c14e99a09f7

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