# FDA 483 - Pine Pharmacy and Home Care Products Center, Inc. - July 19, 2013

Source: https://www.keypedia.com/records/483/pine-pharmacy-and-home-care-products-center-inc/0d93ce91-7137-446f-b81a-57c849264659

> FDA 483 for Pine Pharmacy and Home Care Products Center, Inc. on July 19, 2013. 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: 2013-07-19
- Product Type: Drugs
- Office Name: New York District Office
- Summary: The FDA Form 483 details multiple deficiencies observed during an inspection of a drug manufacturing facility.

**Facility and Operations:** The firm manufactures sterile injectable and ophthalmic drug products, including beta-Lactam non-penicillin drugs like Ceftazidime ophthalmic drops.

**Violations and Observations:**

*   **Equipment Design (21 CFR 211.63):** The cleanroom design is inadequate to maintain ISO 5, ISO 7, and ISO 8 conditions.
    *   Smoke studies were not performed under dynamic conditions to verify unidirectional airflow.
    *   Vinyl strip door curtains at the ISO 7/ISO 8 and ISO 8/unclassified area entryways do not fully cover the doorways (approx. 2 feet open at bottom).
*   **Personnel Clothing (21 CFR 211.28(a)):** Non-sterile gowns are stored in open plastic bags in the ISO 8 anteroom. Non-sterile masks and bonnets are used, leaving facial skin exposed over the ISO 5 laminar flow bench, and no goggles are used.
*   **Microbiological Contamination Prevention (21 CFR 211.113(b)):**
    *   Work surfaces inside the ISO 5 hood are not frequently tested for microbial contamination. Environmental monitoring by an outside contractor is infrequent (every (b)(4) for surfaces, (b)(

## 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 - 2013-12-16](https://www.keypedia.com/records/483/pine-pharmacy-and-home-care-products-center-inc/990fef97-98f0-4b17-a2b4-b12a949deadb)
- [483 - 2016-04-18](https://www.keypedia.com/records/483/pine-pharmacy-and-home-care-products-center-inc/4a20a2c4-b8eb-4aa6-b0c8-8ad940ab291b)
- [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/james-a-liubicich/31b3dad6-b187-458c-8f13-dcf9a758a28b)
- [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/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d