Apicore Pharmaceuticals Private Ltd.
Form 483 issued May 5, 2023 · Vadodara, India
- Inspection
- Apr 27 – May 5, 2023
- Investigator
- Bijoy Panicker
- Observations
- 2
- Pages
- 2
- FEI number
- 3006767695
In short: On May 5, 2023, FDA issued a Form 483 with 2 observations to Apicore Pharmaceuticals Private Ltd. in Vadodara, Gujarat (FEI 3006767695) after an inspection that ran Apr 27 – May 5, 2023. The investigator was Bijoy Panicker. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Routine calibration of electronic equipment is not performed according to a written program designed…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmApicore Pharmaceuticals Private Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apicore Pharmaceuticals Private Ltd.?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Apicore Pharmaceuticals Private Ltd.?
Bijoy Panicker is named on this Form 483, for the inspection of Apr 27 – May 5, 2023. Each investigator has a profile showing what they cite most.
When was Apicore Pharmaceuticals Private Ltd. inspected by FDA?
The inspection ran Apr 27 – May 5, 2023, and the Form 483 is dated May 5, 2023.
How do I get the full Form 483 for Apicore Pharmaceuticals Private Ltd.?
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.