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Time-Cap Laboratories, Inc. FDA Inspection Record

FEI 2431898 · Inspections, Form 483s, warning letters and import refusals

Time-Cap Laboratories, Inc. is an FDA-inspected facility (FEI 2431898) located in Farmingdale, NY, US. RegDataLab tracks 13 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 24, 2025: Voluntary Action Indicated (VAI)
Inspections on record
13 (1 OAI, 10 VAI, 2 NAI)
Last OAI inspection
Dec 5, 2008
Warning letters
1 listed by FDA for this FEI, latest Apr 10, 2009
Form 483 and inspection documents
1 in FDA's reading room
Recalls as the recalling firm
3, latest Jan 11, 2018
Import refusals
4

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Showing the 10 most recent of 13 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 24, 2025Voluntary Action Indicated (VAI)Buildings of Suitable Size, Construction, Location (21 CFR 211.42(a))
Oct 10, 2023No Action Indicated (NAI)No citations listed
Dec 18, 2019Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Mar 12, 2018Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Clothing appropriate for duties performed (21 CFR 211.28(a))
Control procedures to monitor and validate performance (21 CFR 211.110(a))
Scientifically sound laboratory controls (21 CFR 211.160(b))
and 2 more
Mar 10, 2016Voluntary Action Indicated (VAI)GMP Training Frequency (21 CFR 211.25(a))
Testing in same container - closure system (21 CFR 211.166(a)(4))
Jan 16, 2015Voluntary Action Indicated (VAI)Product flow through building is inadequate (21 CFR 211.42(b))
Written procedures not established/followed (21 CFR 211.67(b))
SOPs not followed / documented (21 CFR 211.100(b))
Testing and release for distribution (21 CFR 211.165(a))
and 6 more
Oct 25, 2013Voluntary Action Indicated (VAI)No citations listed
Mar 18, 2013Voluntary Action Indicated (VAI)SOPs not followed / documented (21 CFR 211.100(b))
Written program not followed (21 CFR 211.166(a))
Nov 18, 2011Voluntary Action Indicated (VAI)No citations listed
Feb 17, 2011No Action Indicated (NAI)Prepared for each batch, include complete information (21 CFR 211.188)
Control procedures to monitor and validate performance (21 CFR 211.110(a))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jan 11, 2018Class IID-0685-2018Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC… and 10 more products
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Jun 16, 2017Class IID-1055-2017Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured…
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Jul 9, 2008Class IIID-045-2009Pseudoephedrine HCl 100 mg/Chlorpheniramine Maleate 12 mg Capsules, 100 Capsules, NDC…
Labeling: the lots were labeled with an incorrect expiration date (1 year longer).

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Jul 24, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Time-Cap Laboratories, Inc.
Location
Farmingdale, NY (US)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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