# FDA 483 - Innovative Compounding Pharmacy - April 17, 2015

Source: https://www.keypedia.com/records/483/innovative-compounding-pharmacy/5540be16-b4d4-4a84-9237-8ac4cbe85483

> FDA 483 for Innovative Compounding Pharmacy on April 17, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Innovative Compounding Pharmacy
- Inspection Date: 2015-04-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA Form 483 documents observations from an inspection of a drug manufacturing facility.

**Facility and Operation Details:** The inspection covered areas involved in aseptic processing, including an ISO-5 LAF hood, ISO-7 anteroom, and buffer room. The facility manufactures sterile injectable products, including Testosterone Cypionate 200mg/ml.

**Violations and Observations:**
1.  **Unclean Conditions:** Spatters were observed on the ceiling of the ISO-5 LAF hood on April 13, 2015, despite being logged as clean on April 10, 2015.
2.  **Deficient Cleaning/Disinfection:** Non-sterile wipes were used for the ISO-5 LAF hood, and non-sterile, non-lint-free mop-heads were used for ISO-7 areas. Cleaning procedures for the ISO-5 LAF hood lacked detail. No records demonstrated disinfectant solution effectiveness throughout its period of use.
3.  **Inadequate Environmental Monitoring:** Viable and non-viable particulate monitoring was never performed during routine aseptic filling. Glove touch plate monitoring was inconsistent. The pressure differential gauge between ISO-7 and unclassified areas was not continuously monitored, alarmed, or calibrated. Only one passageway was monitored. Pressure records from January 13 to April 13, 2015, showed 65% of readings below the required 0.0

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## Related Officers

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Company: https://www.keypedia.com/companies/innovative-compounding-pharmacy/22113e00-3e7e-47cf-9c38-2cc4063e7a4d

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