# FDA 483 - Randol Mill Pharmacy - August 06, 2019

Source: https://www.keypedia.com/records/483/randol-mill-pharmacy/43eb2aca-8775-4f84-aea1-2e513d04e3f4

> FDA 483 for Randol Mill Pharmacy on August 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Randol Mill Pharmacy
- Inspection Date: 2019-08-06
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Pandol Mill Pharmacy in Arlington, TX, was inspected by the FDA from July 23 to August 6, 2019, and received a Form 483 with seven observations. The inspection revealed significant deficiencies in aseptic processing, facility design, contamination control, and quality control procedures for sterile drug products. These issues indicate a high risk of microbiological contamination and compromised product quality.

## Related Documents

- [483 - 2019-08-06](https://www.keypedia.com/records/483/randol-mill-pharmacy/6448733b-4eda-4676-8c30-788372ea602f)
- [WARNING_LETTER - 2019-08-06](https://www.keypedia.com/records/warning_letter/randol-mill-pharmacy/f8af0b73-7990-4b66-a290-0c9cea222773)
- [WARNING_LETTER_RESPONSE - 2022-09-28](https://www.keypedia.com/records/warning_letter_response/randol-mill-pharmacy/229ab9aa-be33-4d40-a569-00e16e995026)
- [OTHER_CORRESPONDENCE - 2022-05-16](https://www.keypedia.com/records/other_correspondence/randol-mill-pharmacy/b09e29ca-58d0-41b8-8ce7-39573f356900)

## Related Officers

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

Company: https://www.keypedia.com/companies/randol-mill-pharmacy/1970a9a3-b7ec-402b-8e05-025f95ca43cd

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