# FDA 483 - Pine Pharmacy and Home Care Products Center, Inc. - April 18, 2016

Source: https://www.keypedia.com/records/483/pine-pharmacy-and-home-care-products-center-inc/4a20a2c4-b8eb-4aa6-b0c8-8ad940ab291b

> FDA 483 for Pine Pharmacy and Home Care Products Center, Inc. on April 18, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pine Pharmacy and Home Care Products Center, Inc.
- Inspection Date: 2016-04-18
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 document details observations made during an inspection of Pine Pharmacy and Home Care Products Center, Inc., a sterile drug producer located in Williamsville, NY, from March 30 to April 18, 2016. The inspection revealed several deficiencies in their sterile drug production processes.

**Key Observations:**

1.  **Protective Apparel:** Operators' neck areas were not fully covered, exposing skin over the critical ISO 5 laminar flow area during sterile drug processing. Excessive conversation was also observed between operators in the ISO 5 zone.
2.  **Environmental Monitoring:**
    *   Work surfaces inside ISO 5 hoods were not tested for microbial contamination daily; monitoring was performed less frequently.
    *   Non-viable particulate monitoring was only performed periodically by an outside vendor.
    *   ISO 7 clean rooms, the ISO 7 anteroom, and unclassified surrounding areas were only monitored for air pressure differentials.
3.  **Contamination Prevention (Beta-Lactam Drugs):** No separate facilities existed for processing beta-Lactam injectable drugs (e.g., Ceftazidime), which were processed in the same ISO 5 hood as non-beta-Lactam drugs, posing a contamination risk from potential spills.
4.  **Sterilization Process Validation:** The firm had not validated its sterilization process for sterile drug products (e.g., Progesterone in Sesame Oil

## Related Documents

- [WARNING_LETTER - 2013-12-16](https://www.keypedia.com/records/warning_letter/pine-pharmacy-and-home-care-products-center-inc/65ae33b2-36ca-433d-90c9-346435f8a7ac)
- [483 - 2013-07-19](https://www.keypedia.com/records/483/pine-pharmacy-and-home-care-products-center-inc/0d93ce91-7137-446f-b81a-57c849264659)
- [483 - 2013-12-16](https://www.keypedia.com/records/483/pine-pharmacy-and-home-care-products-center-inc/990fef97-98f0-4b17-a2b4-b12a949deadb)
- [STATE_REFERRAL_LETTER - 2016-03-30](https://www.keypedia.com/records/state_referral_letter/pine-pharmacy-and-home-care-products-center-inc/7c82f98d-177e-4fb5-8139-0ac1f2ec60a3)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/karen-l-kosar/6e58be60-f8e3-44f3-8218-8acdde249724)

Company: https://www.keypedia.com/companies/pine-pharmacy-and-home-care-products-center-inc/38c19287-1839-4367-9933-e65b0691cc19

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