# FDA 483 - Option Care Enterprises, Inc. - February 25, 2016

Source: https://www.keypedia.com/records/483/option-care-enterprises-inc/5b60e17c-00f2-4e67-867a-eba7710b9fb9

> FDA 483 for Option Care Enterprises, Inc. on February 25, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Option Care Enterprises, Inc.
- Inspection Date: 2016-02-25
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: The FDA Form 483 details significant deficiencies in aseptic processing and quality control for sterile injectable drug products.

**Environmental Monitoring and Investigation:**
*   The firm's environmental monitoring system is deficient. Positive environmental microbiological results, specifically gram-negative rods like *Acinetobacter baumannii* (ISO 5, June 16, 2015) and *Brevundimonas intermedia* (ISO 8, December 15, 2015), were not investigated for their impact on sterile products, contrary to SOP P-165.
*   SOP P-165 lacks scientific rationale for environmental monitoring testing frequency.
*   Surface and active air sampling in ISO 5 hoods are not performed daily during sterile drug production, instead conducted (b)(4). Personnel monitoring is also not daily, and the last technician monitoring was on (b)(4).

**Aseptic Processing and Cleanroom Practices:**
*   In situ air pattern analysis (smoke studies) from (b)(4) were not conducted under dynamic conditions, failing to simulate routine filling activities with operators and interventions (e.g., set-up, multiple operators). Documentation of smoke study review and adequacy is absent.
*   Inadequate aseptic techniques were observed on February 9, 2016:
    *   Technician (b)(4) touched non-sterile items and moved in/out of the

## Related Documents

- [STATE_REFERRAL_LETTER - 2016-06-24](https://www.keypedia.com/records/state_referral_letter/option-care-enterprises-inc/888eb394-95f5-4081-82d9-60a34ae817dd)

## Related Officers

- [Sangeeta B. Kamdore](https://www.keypedia.com/people/sangeeta-b-kamdore/86a390a9-2d7d-4612-ac69-1271885c286a)
- [Consumer Safety Officer](https://www.keypedia.com/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.keypedia.com/companies/option-care-enterprises-inc/9a75b45e-8c1a-4985-ad3b-e7e534aa225a

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913