# FDA 483 - Anderson Holdings Inc. - February 19, 2016

Source: https://www.keypedia.com/records/483/anderson-holdings-inc/f19b8302-f4a4-44e1-81d7-365c1f3fc810

> FDA 483 for Anderson Holdings Inc. on February 19, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anderson Holdings Inc.
- Inspection Date: 2016-02-19
- Product Type: Drugs
- Office Name: New England District Office
- Summary: This FDA Form 483 details deficiencies at a facility producing sterile drug products, including Cyclosporin 2% ophthalmic solution and Tri-Mix 30-1-10.

**Aseptic Processing Area Deficiencies:**
*   **Cleaning and Disinfection:** The ISO 5 glove box's front panel is fully opened for daily cleaning, exposing the aseptic area to non-sterile gowning and ISO 8 room air without impact evaluation. Non-sterile solutions (Process LpH st, Vespelne Ise, Sporicidin) and non-sterile, non-shedding wipes are used in the ISO 5 glove box. Dilution of cleaning agents (Process LpH st, Vespelne Ise) with distilled water is not documented. Cleaning logs lack specific cleaning agent documentation for daily/monthly cleanings of ISO 5 and ISO 8 areas.
*   **Environmental Monitoring:** Volumetric viable air and surface contact monitoring in ISO classified areas are only monthly; no routine monitoring of the ISO 5 glove box during aseptic operations (3-4 days/week). Personnel monitoring (fingertip plating) is only during semi-annual media fills, not after routine sterile processing, and does not adhere to the specified frequency. ISO 8 room air pressure is documented daily, but continuous pressure differential monitoring for the ISO 5 glove box is absent. Positive low-level viable air monitoring results in the ISO 8 clean

## Related Documents

- [STATE_REFERRAL_LETTER - 2016-02-10](https://www.keypedia.com/records/state_referral_letter/anderson-holdings-inc/e5cb50ff-a94a-4575-a19d-74ab1071e4cc)

## Related Officers

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Company: https://www.keypedia.com/companies/anderson-holdings-inc/fe35e323-fe8c-4c61-bd9e-bfe3b06b9380

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144