# FDA 483 - Thrifty White Drug #762 - September 21, 2018

Source: https://www.keypedia.com/records/483/thrifty-white-drug-762/fbc4c684-fed5-44bc-b305-5d89e50fbf9e

> FDA 483 for Thrifty White Drug #762 on September 21, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thrifty White Drug #762
- Inspection Date: 2018-09-21
- Product Type: Drugs
- Office Name: Minneapolis District Office
- Summary: On September 10-21, 2018, the FDA inspected Thrifty White Drug #762, a producer of sterile and non-sterile drug products, located at 6055 Nathan Ln N Ste 200A, Minneapolis, MN 55442-1675. The inspection identified six observations.

Observation 1 noted that sporicidal agents were not used in the facility's cleanrooms or ISO 5 aseptic processing area. Specifically, on September 10, 2018, daily cleaning of the ISO 5 area used only L _ (6) (4)1, and no sporicidal agent was used in the [(l5) (4J cleaning.

Observation 2 stated that disinfecting agents and cleaning wipes used in the ISO 5 aseptic processing areas were not sterile. On September 10, 2018, an employee cleaned the ISO 5 area with (6r{4} and non-sterile wipes before aseptic processing.

Observation 3 indicated that equipment and materials were not disinfected prior to entering aseptic processing areas. Items were sprayed with -(15r(4 } in a non-classified area, transported to a non-classified (6) (4 ~area leading to the ISO 7 buffer, and then placed into the ISO 5 aseptic processing area without further disinfection.

Observation 4 highlighted that the ISO

## Related Documents

- [145 - 2020-05-27](https://www.keypedia.com/records/145/thrifty-white-drug-762/0f9752c3-f756-49ec-88cc-f6654d4f41d4)

## Related Officers

- [Ross J. Grigsby](https://www.keypedia.com/people/ross-j-grigsby/713f8252-3e41-4e6f-abea-8ca5bd48aa83)
- [Pharmacist at U.S. Public Health Service Commissioned Corps](https://www.keypedia.com/people/anthony-j-ladner/dbb6b53a-80d1-4b47-ae42-6eb2053dfa4b)

Company: https://www.keypedia.com/companies/thrifty-white-drug-762/6dc216e9-29d3-4647-bfef-e42e02dc5335

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d