# FDA 483 - Prescription Labs Inc dba Greenpark - October 27, 2017

Source: https://www.globalkeysolutions.net/records/483/prescription-labs-inc-dba-greenpark/0d525240-a35e-4253-a840-800ed02c84bd

> FDA 483 for Prescription Labs Inc dba Greenpark on October 27, 2017. 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: 2017-10-27
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: On October 27, 2017, the FDA issued a Form 483 to Prescription Labs, Inc. dba Greenpark Compounding Pharmacy, located at 4061 Bellaire Blvd., Houston, TX 77025-1121, following an inspection from October 16-20, 23-24, and 27, 2017. The firm is a producer of sterile and non-sterile drugs.

The inspection revealed six observations related to aseptic processing and quality control:

1.  **Aseptic Processing Personnel:** On October 17, 2017, an operator performing aseptic processing was observed with partially exposed skin on their upper torso inside the ISO 5 area, while wearing a non-sterile mask, goggles, and hairnet.
2.  **Gloved Hand Sanitization:** On October 17, 2017, an operator sanitized gloved hands with non-sterile solution before resuming aseptic processing in the ISO 5 area.
3.  **Disinfecting Wipes:** Wipes used for disinfecting the interior of the ISO 5 hood were not sterile.
4.  **ISO 5 Area Certification:** The ISO 5 classified areas were not certified under dynamic conditions, specifically, unidirectional air flow was not verified under operational conditions.
5.  **Sterility Testing:** There was no evidence of

## Related Documents

- [483 - 2021-08-12](https://www.globalkeysolutions.net/records/483/prescription-labs-inc-dba-greenpark/0fe5b731-fd87-4238-89e9-511c07e59675)

## Related Officers

- [Principal Consultant](https://www.globalkeysolutions.net/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

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

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