# FDA 483 - Prescription Labs Inc dba Greenpark - August 12, 2021

Source: https://www.keypedia.com/records/483/prescription-labs-inc-dba-greenpark/0fe5b731-fd87-4238-89e9-511c07e59675

> FDA 483 for Prescription Labs Inc dba Greenpark on August 12, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prescription Labs Inc dba Greenpark
- Inspection Date: 2021-08-12
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 details multiple significant violations at a pharmacy engaged in sterile and non-sterile drug compounding.

**Facility and Operations:** The pharmacy produces sterile ophthalmic solutions (e.g., Vancomycin-PF, Spironolactone-PF, Tacrolimus-PF, Acetylcysteine Ophthalmic, Atropine Sulfate Ophthalmic) and injections (e.g., Testosterone Cypionate, Hydroxyprogesterone), as well as non-sterile creams (e.g., Biestrogen, Clobetasol). Operations involve ISO 5 Laminar Airflow Units (LAFUs) and Biological Safety Cabinets (BSCs) within cleanrooms.

**Violations and Observations:**

*   **Aseptic Processing Breaches:** Personnel engaged in aseptic processing were observed with exposed facial skin (non-sterile helmet, eyeglasses, face mask) breaking the plane of the ISO 5 LAFU, directly impacting drug quality. This is a repeat observation.
*   **Product Quality and Release:** The firm released out-of-specification (OOS) drug products, dispensed products after their beyond-use date, and continued dispensing after receiving OOS laboratory results.
*   **Sterilization Deficiencies:**
    *   Failure to conduct post-use filter integrity testing on sterile filters used for products like Spironolactone-PF Ophthalmic. This is a repeat observation, affecting 40 batches (10,000

## Related Documents

- [483 - 2017-10-27](https://www.keypedia.com/records/483/prescription-labs-inc-dba-greenpark/0d525240-a35e-4253-a840-800ed02c84bd)

## Related Officers

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

Company: https://www.keypedia.com/companies/prescription-labs-inc-dba-greenpark/7ee15f3b-68f8-453c-b287-0516a2c485be

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