Lifetime Value Pharmacy III Inc. – FDA Inspection, Feb 21, 2019

Record Details

This FDA Inspection record concerns Lifetime Value Pharmacy III Inc., with an inspection on February 21, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Lifetime Value Pharmacy III Inc.
Inspection Date: February 21, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Christopher R. Czajka (FDA Associated Person)

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ID · 3f5ad609-df8d-46d0-906c-7017afde8dac

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1080372
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

FDCA 501(a)(2)(A)Non-microbial contamination, production area
FDCA 501(a)(2)(A)Non-sterilized and non-depyrogenated, sterile drug
FDCA 501(a)(2)(A)Personnel habits, contamination
FDCA 501(a)(2)(A)Improper gowning, contamination
FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
FDCA 501(a)(2)(A)Ceiling tiles, cleanroom
FDCA 501(a)(2)(A)Actionable microbial contamination, adjacent area
FDCA 501(a)(2)(A)Actionable microbial contamination, ISO 5 area
FDCA 501(a)(2)(A)Air flow quality, higher classified area

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FDA Inspection

Lifetime Value Pharmacy III Inc.February 21, 2019