Time-Cap Laboratories, Inc., Farmingdale, NY – FDA Inspections

Inspection records and compliance data for Time-Cap Laboratories, Inc. in Farmingdale, New York. 13 FDA inspections on record (1 OAI), 2 Form 483s, last inspected April 24, 2025.

Company Profile

This profile covers Time-Cap Laboratories, Inc. based in Farmingdale, New York, United States.

FDA Inspection History

FDA inspections: 13
OAI: 1
VAI: 10
NAI: 2
Form 483s: 2
Warning letters: 0

First inspected December 5, 2008. Last inspected April 24, 2025.

Most cited issue areas

Control procedures to monitor and validate performance3 inspections
Investigations of discrepancies, failures2 inspections
Procedures not in writing, fully followed2 inspections

FDA inspections (13)

Date	Result	FDA center(s)	Insp. #
April 24, 2025	VAI	Human Drugs · Drug Quality Assurance	1263597
October 10, 2023	NAI	Foods & Cosmetics · Food Composition, Standards, Labeling and Econ	1221504
December 18, 2019	VAI	Human Drugs · Drug Quality Assurance	1113101
March 12, 2018	VAI	Human Drugs · Drug Quality Assurance	1043706
March 10, 2016	VAI	Human Drugs · Drug Quality Assurance	963304
January 16, 2015	VAI	Human Drugs · Drug Quality Assurance	909667
October 25, 2013	NAI	Human Drugs · Drug Quality Assurance	852950
March 18, 2013	VAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	826830
November 18, 2011	VAI	Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices	754074
February 17, 2011	VAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	709419
April 1, 2010	VAI	Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices	656296
June 29, 2009	VAI	Human Drugs · Drug Quality Assurance	593781
December 5, 2008	OAI	Animal Drugs & Feeds, Human Drugs · Unapproved and Misbranded Drugs	550181