# FDA 483 - California Pharmacy & Compounding Center - April 21, 2017

Source: https://www.keypedia.com/records/483/california-pharmacy-compounding-center/dc5c6cc4-f8ed-4125-9425-9895bfa1abb7

> FDA 483 for California Pharmacy & Compounding Center on April 21, 2017. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: California Pharmacy & Compounding Center
- Inspection Date: 2017-04-21
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details multiple observations from an inspection conducted at a pharmaceutical facility. The firm failed to protect against insect infestation, evidenced by 23 environmental monitoring deviations with fly larvae contamination in the incubator from 2/26/2016 to 10/10/2016, and dead insects observed in glue traps in the ISO-8 room.

Several structural and material deficiencies were noted. The ISO-5 classified hood's horizontal working surface is laminated particle board, not easily cleanable, with separating edges and exposed particle board underside, risking microbial harborage. Cabinets, a scale's wooden box, and a wooden stool in the ISO-8 room are also made of porous, difficult-to-clean particle board or wood. Particle board dust was observed.

Facility design issues include return vents in the ISO-8 room ceiling located next to HEPA filters, perforations in the ISO-7 room ceiling allowing unfiltered air entry, peeling caulking around a camera wire hole, and taped thermostat wiring. The ISO-8 room entrance has carpet and broken linoleum. An unused plywood door to a non-classified space, sealed with painter's tape, and shedding drywall with a hole were also observed.

Operational and quality control issues include the use of non-sterile containers refilled with sterile solutions in the ISO-7 room, with no assurance of sterility maintenance. A dirty area with stains, gloves, dust,

## Related Documents

- [483 - 2014-08-25](https://www.keypedia.com/records/483/california-pharmacy-compounding-center/910f9dc9-5efa-4441-9c0e-ee0bf62756a7)
- [483 - 2014-10-17](https://www.keypedia.com/records/483/california-pharmacy-compounding-center/d787da6c-fe92-40a5-ae05-cefdf58a1e4d)
- [WARNING_LETTER - 2014-10-17](https://www.keypedia.com/records/warning_letter/california-pharmacy-compounding-center/565ef235-df5b-4460-a90a-04c9ccb32421)
- [483 - 2016-08-31](https://www.keypedia.com/records/483/california-pharmacy-compounding-center/5d52aece-cf3d-4cb0-b3fe-15977471941f)
- [AMENDED_483 - 2018-12-07](https://www.keypedia.com/records/amended_483/california-pharmacy-compounding-center/d8565f55-be32-49dc-a7c6-55fdc3499cc2)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

Company: https://www.keypedia.com/companies/california-pharmacy-compounding-center/d5604546-24b5-4923-acef-416e6a07d32e

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b