Independent Chem Corp
Form 483 issued January 29, 2016 · Glendale, New York
- Inspection
- Jan 21 – Jan 29, 2016
- Investigator
- Alice S. Tsao
- Observations
- 3
- Pages
- 3
- FEI number
- 2419593
In short: On January 29, 2016, FDA issued a Form 483 with 3 observations to Independent Chem Corp in Glendale, New York (FEI 2419593) after an inspection that ran Jan 21 – Jan 29, 2016. The investigator was Alice S. Tsao. Most observations concern packaging & labeling and production.
At a glance
Packaging & labeling and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing in sufficient detail the controls employed for the issuance of labeling…
- 02
Written production and process control procedures are not documented at the…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written…
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 firmIndependent Chem Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.125(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Independent Chem Corp?
FDA listed 3 observations on this Form 483, mostly about packaging & labeling, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Independent Chem Corp?
Alice S. Tsao is named on this Form 483, for the inspection of Jan 21 – Jan 29, 2016. Each investigator has a profile showing what they cite most.
When was Independent Chem Corp inspected by FDA?
The inspection ran Jan 21 – Jan 29, 2016, and the Form 483 is dated January 29, 2016.
How do I get the full Form 483 for Independent Chem Corp?
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.