Medgel Private Limited
Form 483 issued January 27, 2023 · Pithampur, India
- Inspection
- Jan 23 – Jan 27, 2023
- Investigators
- Arsen Karapetyan· Teresa I. Navas
- Observations
- 11
- Pages
- 16
- FEI number
- 3010165392
In short: On January 27, 2023, FDA issued a Form 483 with 11 observations to Medgel Private Limited in Pithampur, Madhya Pradesh (FEI 3010165392) after an inspection that ran Jan 23 – Jan 27, 2023. The investigators were Arsen Karapetyan and Teresa I. Navas. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
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 firmMedgel Private Limited history
All 3 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 Medgel Private Limited?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Medgel Private Limited?
Arsen Karapetyan and Teresa I. Navas are named on this Form 483, for the inspection of Jan 23 – Jan 27, 2023. Each investigator has a profile showing what they cite most.
When was Medgel Private Limited inspected by FDA?
The inspection ran Jan 23 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
How do I get the full Form 483 for Medgel 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.