# FDA 483 - Complete Pharmacy and Medical Solutions, LLC. - February 23, 2017

Source: https://www.globalkeysolutions.net/records/483/complete-pharmacy-and-medical-solutions-llc/654c66d1-7ebb-4380-a244-a0f45c89decd

> FDA 483 for Complete Pharmacy and Medical Solutions, LLC. on February 23, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Complete Pharmacy and Medical Solutions, LLC.
- Inspection Date: 2017-02-23
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: This FDA Form 483 document details observations from an inspection of an outsourcing facility. The inspection revealed two primary violations related to drug product stability and labeling.

Firstly, the facility's stability testing results are not being utilized to determine expiration dates for sterile compounded drug products. The facility lacks analytical and sterility data to support the Beyond Use Dates (BUDs) assigned to these products. While the firm stated their BUDs are based on literature, this information is not specific to their operations, such as container closure data. This indicates a deficiency in their quality system regarding stability programs and data-driven BUD assignments.

Secondly, the labels of the outsourcing facility's drug products do not include all information required by section 503B(a)(10)(A) and (B) of the Federal Food, Drug, and Cosmetic Act. Specifically, the drug product label for "HCG 125 IU/0.5 ml, 0.5 ml pre-filled syringe" does not include the information required by section 503B(a)(10)(A). Additionally, the statement "Office Use Only" is missing from the drug product labels, which is a requirement under section 503B(a)(10)(B). These labeling deficiencies have direct business and operational implications, as non-compliant labels can lead to product recalls or regulatory actions.

## Related Documents

- [483 - 2014-08-12](https://www.globalkeysolutions.net/records/483/complete-pharmacy-and-medical-solutions-llc/a7d084a0-b859-4910-8ac0-464459406bd4)
- [483 - 2019-01-23](https://www.globalkeysolutions.net/records/483/complete-pharmacy-and-medical-solutions-llc/87481a42-0fd4-44cb-bb83-33f1e72a734d)

## Related Officers

- [Special Assistant](https://www.globalkeysolutions.net/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.globalkeysolutions.net/companies/complete-pharmacy-and-medical-solutions-llc/83391c27-715b-4ed9-9d88-9dd6c6b3d2a2

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9