Drug factory · FDA FEI 2431898

Time Cap Laboratories, Inc.

7 Michael Avenue, Farmingdale, NY, United States

Problems found, fixed voluntarily at FDA's last inspection, Apr 24, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

14 drug inspections on record since 2008: 1 with no problems, 11 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Nitroglycerin	Makes it	Time Cap Laboratories	49483-221, 49483-222, 49483-223

Ended	Result	Program	Problems noted
Apr 24, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	1
Dec 18, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	3
Mar 12, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	6
Mar 10, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jan 16, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	10
Oct 25, 2013	Problems found, fixed voluntarily	Unapproved and Misbranded Drugs	—
Oct 25, 2013	No problems found	Drug Quality Assurance	—
Mar 18, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	2
Nov 18, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 17, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	2
Apr 1, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 29, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	3
Dec 5, 2008	Serious problems, FDA action	Unapproved and Misbranded Drugs	—
Dec 5, 2008	Serious problems, FDA action	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.

Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity.
Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Clothing appropriate for duties performed 21 CFR 211.28(a)
Clothing of personnel engaged in the manufacturing and packing of drug products is not appropriate for the duties they perform.

Testing in same container - closure system 21 CFR 211.166(a)(4)
The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

Registered with FDA for: manufacture.