# FDA 483 - Buderer Drug Company - February 14, 2019

Source: https://www.keypedia.com/records/483/buderer-drug-company/dfe7532a-f69f-4969-a46c-24d421ef8b80

> FDA 483 for Buderer Drug Company on February 14, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Buderer Drug Company
- Inspection Date: 2019-02-14
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: On February 14, 2019, the FDA issued a Form 483 to Buderer Drug Company, a producer of non-sterile drug products located at 38530 Chester Road, Suite 400, Avon, Ohio 44011. The inspection, conducted from February 7-14, 2019, identified one observation.

The primary violation noted was the use of a non-pharmaceutical grade component, [(b) (4)], in the formulation of non-sterile drug products, specifically topical creams for severe muscular pain. From 2012 to 2019, approximately [(b) (4)] prescriptions were produced using this component. Examples include Ketoprofen 5% Gel, prepared [(b) (4)] times, and [(b) (4)] base, used in over [(b) (4)] different non-sterile drug formulas, resulting in [(b) (4)] prescriptions. Additionally, from 2013 to 2019, a cream named Ultracaine-Benzocaine 20%, Lidocaine 8%, Tetracaine 4%, Ibuprofen 2%, Bupivacaine 0.5% also utilized [(b) (4)]. The FDA found no evidence that the [(b) (4)] used in these creams and liquid non-sterile drug products was of appropriate quality for its intended use.

## Related Documents

- [483 - 2019-02-14](https://www.keypedia.com/records/483/buderer-drug-company/2bdfc863-2dc9-4e3c-a3ae-d0a559bda266)

## Related Officers

- [Program Analyst](https://www.keypedia.com/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)

Company: https://www.keypedia.com/companies/buderer-drug-company/88fb9aee-8c50-4f27-93b7-7f0918a23597

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22