# FDA 483 - Compounding Pharmacy of America - February 01, 2018

Source: https://www.keypedia.com/records/483/compounding-pharmacy-of-america/75bc8f25-093e-4f20-a1c4-2ddb773afa5a

> FDA 483 for Compounding Pharmacy of America on February 01, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Compounding Pharmacy of America
- Inspection Date: 2018-02-01
- Product Type: Drugs
- Summary: This FDA Form 483 was issued to The Compounding Pharmacy of America, located at 6216 Highland Place Way, Suite 101-A, Knoxville, TN 37919. The inspection, conducted by Brandon C. Heitmeier, took place from January 23-26, 2018; January 29, 2018; and February 1, 2018. The firm is identified as a producer of sterile and non-sterile drugs. The report was issued to Victor A. Poteet, Co-owner & CEO.

Two observations were noted:

1.  Media fills did not adequately simulate aseptic production operations, failing to incorporate worst-case activities and conditions. Specifically, the firm's large batch media fill used (b)(4) vials, while routine sterile drug product batches, such as (b)(4) (lidocaine) and Methylcobalamin 1000 MCG/ML, frequently exceed (b)(4) vials, with examples provided of batch volumes of (b)(4) and (b)(4) respectively.

2.  Hazardous drugs were produced without adequate containment, segregation, and/or cleaning to prevent cross-contamination. Specifically, hormone and non-hormone drug products are prepared and processed in the same sterile prep area and clean room, utilizing the same equipment ((b)(4) & LAFH

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## Related Officers

- [Brandon C. Heitmeier](https://www.keypedia.com/people/brandon-c-heitmeier/09e1b64b-01de-4f8b-819a-1179d8b4c0c1)

Company: https://www.keypedia.com/companies/compounding-pharmacy-of-america/830c4791-7e4c-4fa8-97d6-52d2578e6eef