# FDA 483 - Allermed Laboratories, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/allermed-laboratories-llc/f5b29065-1393-45d1-bdda-68143fe86a4c

> FDA 483 for Allermed Laboratories, LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allermed Laboratories, LLC
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Allermed Laboratories Inc. in San Diego, CA, an allergenic manufacturer, revealed significant deficiencies. Observations included inadequate validation protocols for sterile allergenic extract bulk holding times, insufficient microbial monitoring procedures for cleanroom personnel during aseptic processing, and a deficient media fill process that did not ensure contact with container closures. These issues indicate a lack of control over critical manufacturing processes.

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Company: https://www.keypedia.com/companies/allermed-laboratories-llc/6eaaa8cd-b3e9-4008-946a-16ad587c9bbe

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1