Eskayef Pharmaceuticals Limited
Form 483 issued April 13, 2022 · Tongi, Bangladesh
- Inspection
- Apr 3 – Apr 13, 2022
- Investigator
- Arsen Karapetyan
- Observations
- 6
- Pages
- 8
- FEI number
- 3014835149
In short: On April 13, 2022, FDA issued a Form 483 with 6 observations to Eskayef Pharmaceuticals Limited in Tongi, Gazipur (FEI 3014835149) after an inspection that ran Apr 3 – Apr 13, 2022. The investigator was Arsen Karapetyan. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 5 of 6 observations.
Most cited: 21 CFR 211.22 (2×)
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…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
The responsibilities and procedures applicable to the quality control unit are not in writing and fully…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmEskayef Pharmaceuticals Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eskayef Pharmaceuticals Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. 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 Eskayef Pharmaceuticals Limited?
Arsen Karapetyan is named on this Form 483, for the inspection of Apr 3 – Apr 13, 2022. Each investigator has a profile showing what they cite most.
When was Eskayef Pharmaceuticals Limited inspected by FDA?
The inspection ran Apr 3 – Apr 13, 2022, and the Form 483 is dated April 13, 2022.
How do I get the full Form 483 for Eskayef Pharmaceuticals 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.