# FDA 483 - Claremore Compounding Center, Inc. - January 24, 2020

Source: https://www.keypedia.com/records/483/claremore-compounding-center-inc/1528fd5a-1bdc-46e9-91a6-70a3cd2b5073

> FDA 483 for Claremore Compounding Center, Inc. on January 24, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Claremore Compounding Center, Inc.
- Inspection Date: 2020-01-24
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details observations from an inspection, citing multiple deficiencies in drug product manufacturing. The facility used a non-pharmaceutical grade component, specifically orange food color, in drug products such as hydrocodone/dextromethorphan 10mg/10mg capsules (Lot #95806, 12/10/19) and 5mg/5mg capsules (Lot #94010, 9/11/19).

A significant quality system issue is the absence of a written stability testing program to determine Beyond Use Dates (BUD)/expiration dates for drug products. Examples include Dry Skin Moisturizing (OTC) 5% - 1% Cream (Lot #95371, 11/20/19) assigned a 360-day BUD, and CCC Cold Max and CCC Cough PE suspensions (Lots #94404 and #94402, 10/1/19) assigned 180-day BUDs. Jungle Juice Liquid (Lots #92698, #93496, #94749) also received a 360-day BUD without a stability program.

Furthermore, the firm does not conduct routine potency testing for all drug products prior to release, failing to ensure conformance to final specifications and identity/strength of active ingredients. This

## Related Documents

- [483 - 2020-01-24](https://www.keypedia.com/records/483/claremore-compounding-center-inc/60364500-bcf5-426d-b735-f719007dd216)

## Related Officers

- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/claremore-compounding-center-inc/ad9168e6-9a78-4dde-aa4e-631220f20347

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