# FDA 483 - Triad Rx, Inc - July 21, 2017

Source: https://www.keypedia.com/records/483/triad-rx-inc/3e6c67dc-eda2-47fa-b9d0-e34849c5beba

> FDA 483 for Triad Rx, Inc on July 21, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Triad Rx, Inc
- Inspection Date: 2017-07-21
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: An FDA Form 483 was issued following an inspection on July 17, 2017, identifying several deficiencies in aseptic processing and cleanroom operations.

**Facility and Operations:** The inspection observed activities in ISO 5 and ISO 7 classified areas, involving lyophilization and aseptic filling of drug products such as Sermorelin Acetate.

**Violations and Observations:**
*   **Non-Sterile Wipes:** Cleaning pads/wipes (specifically (b)(4) wipers) used in the ISO 5 area were not sterile.
*   **Difficult-to-Clean Equipment:** A lyophilizer and portable dehumidifier in the ISO 7 cleanroom, adjacent to ISO 5, were noted as difficult to clean, particle-generating, or visibly dirty.
*   **Product Exposure:** Drug products intended for lyophilization were (b)(4) in the ISO 5 area, partially stoppered, and then transferred to the ISO 7 lyophilizer via unprotected/uncovered trays, exposing them to air quality lower than ISO 5.
*   **Glove Contamination:** An operator (initials (b)(6)) performed aseptic processing in the ISO 5 area without consistently disinfecting or changing gloves after touching surfaces or retrieving materials/discarding waste in the ISO 7 area. This affected lots including Sermorelin Acetate 9mg/GHRP-2 9mg Lyophilized, lot 07

## Related Documents

- [WARNING_LETTER - 2017-07-21](https://www.keypedia.com/records/warning_letter/triad-rx-inc/6a4d5c56-3268-4d39-9265-e3ac66fe17ff)
- [483 - 2022-12-08](https://www.keypedia.com/records/483/triad-rx-inc/be9ccae6-6894-47ff-922e-63a0ce4498ca)
- [STATE_REFERRAL_LETTER - 2022-12-05](https://www.keypedia.com/records/state_referral_letter/triad-rx-inc/ab438325-636f-4c4a-875b-d37ee65515e1)
- [WARNING_LETTER_RESPONSE - 2023-05-03](https://www.keypedia.com/records/warning_letter_response/triad-rx-inc/36ae299e-a7c0-423a-9032-073fdeb89854)

## Related Officers

- [Interdisciplinary Scientist](https://www.keypedia.com/people/brendon-helimeler/183a9fbc-4666-4eba-9ed4-10c7f7daf5ec)

Company: https://www.keypedia.com/companies/triad-rx-inc/0f99b7d5-b246-48c1-b8cf-e987b6706d48

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea