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

Source: https://www.keypedia.com/records/483/randol-mill-pharmacy/6448733b-4eda-4676-8c30-788372ea602f

> 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: Center for Drug Evaluation and Research
- Summary: During an inspection from July 23 to August 6, 2019, Randol Mill Pharmacy, a producer of sterile and non-sterile drug products located at 1014 N Fielder Rd, Arlington, TX, received a Form FDA 483 with seven observations.

Key violations include:
1.  **Aseptic Processing Deficiencies:** A pharmacy technician's eyebrows were exposed in the ISO 5 LAF hood during aseptic processing of Progesterone Cottonseed Oil 100 mg/ml injectable.
2.  **Non-Sterilized Equipment Use:** Non-sterilized syringes, a (b)(4) and metal cap crimper were used in the ISO 5 LAF hood. The technician also failed to disinfect two syringes and re-sanitize hands after re-entering the ISO 5 area multiple times. The firm's sporicidal agent, (b)(4) Solution, was found inadequate for the aseptic processing area.
3.  **Facility Design Flaws:** The cleanroom design allowed poor-quality air into the ISO 7 area. A portable A/C unit feeding the ISO 7 cleanroom (where the ISO 5 LAF is located) lacked maintenance records and air quality assessment. Wall-mounted HEPA filters in ISO 8 and ISO 7 areas were not assessed for adequate airflow, and airflow vents were obstructed.
4.  **Cross-Contamination Risk:**

## Related Documents

- [483 - 2019-08-06](https://www.keypedia.com/records/483/randol-mill-pharmacy/43eb2aca-8775-4f84-aea1-2e513d04e3f4)
- [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/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c