Port Jervis Laboratories, Inc
Form 483 issued November 4, 2022 · Port Jervis, New York
- Inspection
- Oct 31 – Nov 4, 2022
- Investigator
- Sayyem H. Akbar
- Observations
- 2
- Pages
- 3
- FEI number
- 1317131
In short: On November 4, 2022, FDA issued a Form 483 with 2 observations to Port Jervis Laboratories, Inc in Port Jervis, New York (FEI 1317131) after an inspection that ran Oct 31 – Nov 4, 2022. The investigator was Sayyem H. Akbar. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.160(b)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Sayyem H. Akbar
3 documents · 2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmPort Jervis Laboratories, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Port Jervis Laboratories, Inc?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Port Jervis Laboratories, Inc?
Sayyem H. Akbar is named on this Form 483, for the inspection of Oct 31 – Nov 4, 2022. Each investigator has a profile showing what they cite most.
When was Port Jervis Laboratories, Inc inspected by FDA?
The inspection ran Oct 31 – Nov 4, 2022, and the Form 483 is dated November 4, 2022.
How do I get the full Form 483 for Port Jervis Laboratories, 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.