LNK International, Inc.
Form 483 issued March 7, 2017 · Hauppauge, New York
- Inspection
- Feb 28 – Mar 7, 2017
- Investigator
- Sony Mathews
- Observations
- 2
- Pages
- 3
- FEI number
- 2432212
In short: On March 7, 2017, FDA issued a Form 483 with 2 observations to LNK International, Inc. in Hauppauge, New York (FEI 2432212) after an inspection that ran Feb 28 – Mar 7, 2017. The investigator was Sony Mathews. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Materials and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.80(b) (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There was a failure to handle and store drug product containers and closures at all times…
- 02
Failure to maintain a backup file of data entered into the computer or related system. Electronic…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmLNK International, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LNK International, Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected LNK International, Inc.?
Sony Mathews is named on this Form 483, for the inspection of Feb 28 – Mar 7, 2017. Each investigator has a profile showing what they cite most.
When was LNK International, Inc. inspected by FDA?
The inspection ran Feb 28 – Mar 7, 2017, and the Form 483 is dated March 7, 2017.
How do I get the full Form 483 for LNK International, 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.