# FDA 483 - Clark Professional Pharmacy, LLC - January 29, 2016

Source: https://www.keypedia.com/records/483/clark-professional-pharmacy-llc/e34e1261-d713-4477-b0b0-c9e9c8c963e7

> FDA 483 for Clark Professional Pharmacy, LLC on January 29, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clark Professional Pharmacy, LLC
- Inspection Date: 2016-01-29
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On January 29, 2016, the FDA issued a Form 483 to Clark Professional Pharmacy, LLC, a producer of sterile drug products located at 3280 Washtenaw Avenue, Ann Arbor, MI 48104. The inspection, conducted from January 12-29, 2016, by Emily J. Orban and Abuzar Shamim, identified eight observations regarding the facility's sterile drug product manufacturing practices.

Key observations include:

1.  **Lack of validated aseptic processing procedures:** Process simulations (media fills) were not representative of worst-case conditions, gloved hands were not consistently sanitized, the autoclave used for terminal sterilization lacked validation documentation, and bioburden of non-sterile components was not evaluated.
2.  **Inadequate personnel gowning:** Operators performing aseptic operations in the "ISO 5" glove box wore non-sterile protective gowns and face masks.
3.  **Deficient cleaning and disinfection of aseptic areas:** Non-sterile disposable wipes were used in the "ISO 5" glove box, and not all sanitizers and cleaning agents used in classified areas were sterile.
4.  **Inadequate environmental monitoring:** Non-viable and viable particulate/air monitoring were performed only once every six months, viable surface monitoring once per week, and incubators for environmental samples lacked qualification data and proper temperature control/justification.
5.

## Related Documents

- [STATE_REFERRAL_LETTER - 2016-01-12](https://www.keypedia.com/records/state_referral_letter/clark-professional-pharmacy-llc/c582cf90-07cf-4073-b532-55223cc84fb8)

## Related Officers

- [Abuzar Shamim](https://www.keypedia.com/people/abuzar-shamim/3664a0ca-669b-4be7-9cc3-5f84ee4ba0a3)
- [Emily J. Orban](https://www.keypedia.com/people/emily-j-orban/e0008df4-4986-413d-a943-9fafcf385021)

Company: https://www.keypedia.com/companies/clark-professional-pharmacy-llc/b17bc0f4-d8a1-4ddd-a501-bd6bdb3d90f7

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c