FDA WARNING_LETTER - Family Beginnings, PC - May 08, 2012

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The FDA conducted an inspection of Family Beginnings, PC from May 1-8, 2012, identifying significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Violations include: 1. Failure to test reproductive donors for relevant communicable disease agents (21 CFR 1271.85(a)). Examples cited include directed semen donor (b)(6) not tested for HIV-1/2, HBV, HCV, and *Treponema pallidum*; and directed oocyte donor (b)(6) not tested for HIV-1 NAT, HCV NAT, and *Treponema pallidum*. 2. Failure to test viable, leukocyte-rich cell/tissue donors for HTLV-I/II and CMV (21 CFR 1271.85(b)), exemplified by directed semen donor (b)(6). 3. Failure to test reproductive donors for genitourinary tract communicable disease agents (21 CFR 1271.85(c)), such as anonymous oocyte donor (b)(6) not tested for *Chlamydia trachomatis* and *Neisseria gonorrhea*. 4. Failure to determine donor ineligibility based on risk factors (21 CFR 1271.75(d)), as directed semen donor (

Company: Family Beginnings, PC
Inspection Date: May 8, 2012
Product Type: Biologics
Office: Department of Health and Human Services
Person: Glenn T. Bass (Director)

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ID · 933c7d66-2588-4a0d-8142-4ee90fc4e11b

Violation Codes10

21 CFR 127121 CFR 1271.85(a)21 CFR 1271.85(b)21 CFR 1271.85(c)21 CFR 1271.75(d)21 CFR 1271.75(a)21 CFR 1271.5021 CFR 1271.8021 CFR 1271.80(b)21 CFR 1271.65(b)(1)

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