FDA Inspection 1017589 — Alabama Fertility Specialists, PC

Alabama Fertility Specialists, PC — FEI 3005056987

The FDA completed an inspection of Alabama Fertility Specialists, PC on May 4, 2017 in Homewood, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
May 4, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Homewood, AL (United States)

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1224621 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.