AMOL PHARMACEUTICALS PRIVATE LIMITED
Form 483 issued February 16, 2018 · Jaipur, India
- Investigator
- Pratik S. Upadhyay
- Observations
- 11
- Pages
- 19
- FEI number
- 3003925108
In short: On February 16, 2018, FDA issued a Form 483 with 11 observations to AMOL PHARMACEUTICALS PRIVATE LIMITED in Jaipur, Rajasthan (FEI 3003925108). The investigator was Pratik S. Upadhyay. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.186 (master production and control records).
At a glance
Production and laboratory controls account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 04
Laboratory records are deficient in that they do not include the initials and signature of the…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAMOL PHARMACEUTICALS PRIVATE LIMITED history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AMOL PHARMACEUTICALS PRIVATE LIMITED?
FDA listed 11 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.186 (master production and control records). The opening words of each observation are shown on this page.
Who inspected AMOL PHARMACEUTICALS PRIVATE LIMITED?
Pratik S. Upadhyay is named on this Form 483. Each investigator has a profile showing what they cite most.
When was AMOL PHARMACEUTICALS PRIVATE LIMITED inspected by FDA?
This Form 483 is dated February 16, 2018.
How do I get the full Form 483 for AMOL PHARMACEUTICALS PRIVATE LIMITED?
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.