# FDA 483 - VP Pharmacy Partners LLC - February 03, 2015

Source: https://www.keypedia.com/records/483/vp-pharmacy-partners-llc/cef59553-eee5-41ce-a19b-67778e10161a

> FDA 483 for VP Pharmacy Partners LLC on February 03, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VP Pharmacy Partners LLC
- Inspection Date: 2015-02-03
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Spoonamore Drug Co Inc, a sterile drug producer located at 4014 Dutchmans Lane, Louisville, KY, was conducted from January 13, 2015, to February 3, 2015. The inspection revealed seven observations.

Observation 1 noted deficiencies in environmental monitoring within aseptic processing areas. Specifically, there were no records for pressure differential limits between ISO 5 laminar flow hoods and the ISO 7 Buffer/IV Prep Room, or between the Buffer/IV Prep Room and the ISO 8 Anteroom. Pressure gauges were absent for monitoring air pressure between ISO 7 and ISO 8 areas, and no environmental monitoring samples were taken from the curtain door between the ISO 7 I.V. Prep Room and the ISO 8 anteroom.

Observation 2 indicated that an adequate number of batches of each drug product were not tested to determine appropriate expiration dates. This included a lack of stability test data for Tri-Mix injections (30-2-20, 30-1-20, 15-1-10) with a 120-day beyond use date, Bi-Mix 30-1 injection with a 180-day beyond use date, and Vancomycin and Tobramycin beads with a 180-day beyond use date.

Observation 3 stated that each batch of drug product purporting to be sterile

## Related Documents

- [WARNING_LETTER - 2015-02-03](https://www.keypedia.com/records/warning_letter/vp-pharmacy-partners-llc/4964be5c-9a4e-44b9-9f3b-bd4e3c4a766e)
- [483 - 2017-03-14](https://www.keypedia.com/records/483/vp-pharmacy-partners-llc/39ccdf30-0e3a-4ee1-a347-abf65828a93b)
- [STATE_REFERRAL_LETTER - 2017-01-17](https://www.keypedia.com/records/state_referral_letter/vp-pharmacy-partners-llc/c365e2cd-abc5-4a09-9609-3ebc80c4be1d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kathleen-dant-culver/fe43f228-7c7a-47ea-94cb-349324553012)

Company: https://www.keypedia.com/companies/vp-pharmacy-partners-llc/4f464480-1d40-4a37-b3b2-eb4bae025d35

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22