Sciarra Laboratories, Inc
Form 483 issued August 7, 2023 · Hicksville, New York
- Inspection
- Jul 24 – Aug 7, 2023
- Investigators
- Gam S. Zamil· Karishma G. Gopaul
- Observations
- 6
- Pages
- 6
- FEI number
- 1000306996
In short: On August 7, 2023, FDA issued a Form 483 with 6 observations to Sciarra Laboratories, Inc in Hicksville, New York (FEI 1000306996) after an inspection that ran Jul 24 – Aug 7, 2023. The investigators were Gam S. Zamil and Karishma G. Gopaul. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 02
Control procediues are not established which validate the performance of those manufacturing processes that may be…
- 03
The written stability testing…
- 04
Established test procedures are not documented at…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmSciarra Laboratories, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sciarra Laboratories, Inc?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sciarra Laboratories, Inc?
Gam S. Zamil and Karishma G. Gopaul are named on this Form 483, for the inspection of Jul 24 – Aug 7, 2023. Each investigator has a profile showing what they cite most.
When was Sciarra Laboratories, Inc inspected by FDA?
The inspection ran Jul 24 – Aug 7, 2023, and the Form 483 is dated August 7, 2023.
How do I get the full Form 483 for Sciarra 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.