Time Cap Labs, Inc.
Form 483 issued January 16, 2015 · Farmingdale, New York
- Inspection
- Jan 7 – Jan 16, 2015
- Investigators
- Alice S. Tsao· Charanjeet S. Jassal
- Observations
- 10
- Pages
- 5
- FEI number
- 2431898
In short: On January 16, 2015, FDA issued a Form 483 with 10 observations to Time Cap Labs, Inc. in Farmingdale, New York (FEI 2431898) after an inspection that ran Jan 7 – Jan 16, 2015. The investigators were Alice S. Tsao and Charanjeet S. Jassal. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Laboratory controls and production account for 6 of 10 observations.
Most cited: 21 CFR 211.67(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Written procedures for cleaning and maintenance fail to include parameters…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmTime Cap Labs, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Time Cap Labs, Inc.?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Time Cap Labs, Inc.?
Alice S. Tsao and Charanjeet S. Jassal are named on this Form 483, for the inspection of Jan 7 – Jan 16, 2015. Each investigator has a profile showing what they cite most.
When was Time Cap Labs, Inc. inspected by FDA?
The inspection ran Jan 7 – Jan 16, 2015, and the Form 483 is dated January 16, 2015.
How do I get the full Form 483 for Time Cap Labs, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.