# FDA 483 - Town Total Compounding Center - April 20, 2016

Source: https://www.keypedia.com/records/483/town-total-compounding-center/4a617174-d87b-4ca0-94d5-48796245524e

> FDA 483 for Town Total Compounding Center on April 20, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Town Total Compounding Center
- Inspection Date: 2016-04-20
- Product Type: Drugs
- Office Name: New York District Office
- Summary: The FDA Form 483 inspection revealed multiple deficiencies at the facility related to drug product stability, aseptic processing, and environmental monitoring.

**Stability Program and Expiry Dates:**
*   No written testing program for drug product stability.
*   No written stability program for sterile compounded sterile preparations (CSPs) to support assigned expiration dates.
*   Failure to follow the written SOP "Assignment of Beyond-Use Date for Sterile Compounded Preparations" when assigning expiry dates.
*   Preservative-free products lacking adequate stability data and sterility tests were assigned beyond-use dates exceeding written procedure requirements.
*   Examples of specific products with extended expiry dates include Glycerin 100% (Lot 44462015, 180 days), Glycerin 72% (Lot 03252016@10, 90 days), Glycerin 72%/Lido1%-Epi 1:100000 (90 days), Pilocarpine HCl 2% Oph Soln (28 days), Ceftriaxone Nasal 2.5ml (90 days), and Trimix #4 (90 days).
*   Glycerin 100% Lot 44462015 was sterilized below the required sterilization.
*   Products with preservatives, lacking stability and sterility data, were assigned expiry dates

## Related Documents

- [STATE_REFERRAL_LETTER - 2016-04-12](https://www.keypedia.com/records/state_referral_letter/town-total-compounding-center/5fd56bf6-5fcd-47d4-8b00-33cfca621a96)

## Related Officers

- [Demitria Xiradakis](https://www.keypedia.com/people/demitria-xiradakis/f5513905-9be1-49af-865f-2bc14c192f77)

Company: https://www.keypedia.com/companies/town-total-compounding-center/6c41b8b4-3020-42e9-b055-daa7191737e3

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d