# FDA 483 - California Specialty Pharmacy Inc. - May 17, 2019

Source: https://www.keypedia.com/records/483/california-specialty-pharmacy-inc/ce18abc2-34ff-4b10-be21-b0a76524b1b8

> FDA 483 for California Specialty Pharmacy Inc. on May 17, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: California Specialty Pharmacy Inc.
- Inspection Date: 2019-05-17
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: This FDA Form 483 document details observations from an inspection regarding the use of non-pharmaceutical grade components in drug product formulations. The firm used components not of pharmaceutical grade to produce various drug products.

Specifically, non-pharmaceutical grade (b)(4) water was purchased and utilized in the production of multiple nasal spray drug products. Examples include approximately (b)(4) lots of C-Ketamine Nasal Spray and (b)(4) lots of C-Oxycotin 24 units/mL Nasal Spray, both produced between February and May 2019. Additionally, approximately (b)(4) lot of C-Lidocaine HCl 4% Glycerin Nasal Spray was produced in April 2019 using this water. The firm has not submitted samples of this (b)(4) water to a contract laboratory for testing of microbial limits or other analytical properties to demonstrate equivalence to pharmaceutical grade water.

Furthermore, non-pharmaceutical grade Oxytocin was purchased and incorporated into non-sterile sublingual tablet and non-sterile nasal spray drug products. An example cited is approximately (b)(4) lots of C-Oxytoin Sublingual Tablets, produced between February and May 2019.

## Related Officers

- [Stephanie A. Slater](https://www.keypedia.com/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

Company: https://www.keypedia.com/companies/california-specialty-pharmacy-inc/85daab3c-601f-42f7-a50e-e478c31eb596

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