# FDA 483 - Trone Health Services, Inc. - July 15, 2016

Source: https://www.keypedia.com/records/483/trone-health-services-inc/efe4af61-c3cf-4b36-837c-5add7ebee38c

> FDA 483 for Trone Health Services, Inc. on July 15, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Trone Health Services, Inc.
- Inspection Date: 2016-07-15
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: The FDA Form 483 details significant deficiencies in the facility's aseptic processing and quality control for drug products. Sterile drugs, including Acetylcysteine Ophthalmic 10% Solution and Gentamicin Irrigation Solution 80 MG/60 ML Solution, were produced in an unclassified AirClean Systems PowderSafe™ 700 series Ductless Balance Enclosure within an ISO 8 laboratory, not under the required ISO 5 conditions. The enclosure itself showed residue and stains, lacking controls for microbial, endotoxin, and chemical/physical contamination.

The facility lacks a written stability testing program. Expired Active Pharmaceutical Ingredients (APIs) and components were used in drug products, and their Beyond Use Dates (BUDs) or Discard After dates exceeded the API/component expiration. Examples include DHEA E4M 6MG, Acetylcysteine Ophthalmic 10% Solution, Testosterone Cypionate Sesame 200 MG/GM Injectable, Baclofen 20 MG/ML Oral Suspension, and Dream Cream (A/L-A/S/T) Cream. Inconsistencies between BUDs and "Discard After" dates for products like Acetylcysteine Ophthalmic 10% Solution and Baclofen 20 MG/ML Oral Suspension also lacked stability data.

Control procedures for mixing uniformity are inadequate; for DHEA CR 6 MG Capsule, manual mixing in a mortar and pestle

## Related Documents

- [483_RESPONSE - 2016-07-15](https://www.keypedia.com/records/483_response/trone-health-services-inc/3b1f79d5-5f89-43ce-acdd-138cb97b6a67)
- [483 - 2017-11-21](https://www.keypedia.com/records/483/trone-health-services-inc/32608c33-b1e9-4ffc-b91b-11e1fbcfc29a)
- [STATE_REFERRAL_LETTER - 2017-11-02](https://www.keypedia.com/records/state_referral_letter/trone-health-services-inc/6725475b-0556-4106-bbd6-6a7a13b3e458)

## Related Officers

- [Project Manager](https://www.keypedia.com/people/nancy-e-byerly/836e1285-c6b4-4bfd-bf65-1b76fd551d62)
- [Senior Director, Precision Medicine and Innovative Strategies](https://www.keypedia.com/people/tracy-k-li/dce1757a-bb2a-462c-868c-bae77168a764)

Company: https://www.keypedia.com/companies/trone-health-services-inc/33206781-a23d-4cd8-ac88-216148ec389b

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913